Cold and Flu

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl · Solution · Oral, Sublingual

Over the counter Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist alpha-1 Adrenergic Agonist

Active ingredient

Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

Uses temporarily relieves these common cold and flu symptoms: sinus congestion and pressure headache sore throat nasal congestion cough minor aches and pains temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease diabetes thyroid disease heart disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not use

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use

Ask a doctor before use if you have liver disease diabetes thyroid disease heart disease high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product

When using this product do not exceed recommended dosage.

Stop use and ask a doctor

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Directions do not take more than directed do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use

Other information

Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Inactive ingredients

Inactive ingredients corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions?

Questions or comments? 1-800-426-9391

Label text from the FDA structured product label by Meijer Distribution, Inc. (revised Aug 26, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Acetaminophen in 44 products
Dextromethorphan Hydrobromide in 44 products
Phenylephrine Hydrochloride in 24 products
Doxylamine Succinate in 16 products
Guaifenesin in 12 products
Triprolidine Hydrochloride in 4 products
European Elderberry in 1 product
Berberis Vulgaris Root in 1 product
Solidago Canadensis Flowering Top in 1 product
Achillea Millefolium Flowering Top in 1 product
Holy Basil Leaf in 1 product
Garlic in 1 product

Cold and Flu NDC products (57)

NDC	Strength & form	Labeler	Type
55301-310	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	ARMY AND AIR FORCE EXCHANGE SERVICE	OTC MONOGRAPH DRUG
55301-547	Kit	ARMY AND AIR FORCE EXCHANGE SERVICE	OTC MONOGRAPH DRUG
55301-712	Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Solution	ARMY AND AIR FORCE EXCHANGE SERVICE	OTC MONOGRAPH DRUG
63941-344	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid	Best Choice (Valu Merchandisers Company)	OTC MONOGRAPH DRUG
63941-343	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid	Best Choice (Valu Merchandisers Company)	OTC MONOGRAPH DRUG
37835-526	Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Solution	Bi-Mart	OTC MONOGRAPH DRUG
37835-524	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	Bi-Mart	OTC MONOGRAPH DRUG
70000-0673	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	Cardinal Health 110, LLC. DBA Leader	OTC MONOGRAPH DRUG
51316-963	Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Triprolidine Hydrochloride 2.5 mg/20mL Solution	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	OTC MONOGRAPH DRUG
51316-123	Kit	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	OTC MONOGRAPH DRUG
55910-443	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	OTC MONOGRAPH DRUG
55910-573	Kit	DOLGENCORP, LLC	OTC MONOGRAPH DRUG
49035-193	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	OTC MONOGRAPH DRUG
50804-503	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	Geiss, Destin & Dunn Inc.	OTC MONOGRAPH DRUG
42507-700	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled	HyVee Inc	OTC MONOGRAPH DRUG
42507-522	Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Solution	HyVee Inc	OTC MONOGRAPH DRUG
42507-401	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	HyVee Inc	OTC MONOGRAPH DRUG
42507-001	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	HyVee Inc	OTC MONOGRAPH DRUG
42507-056	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 15 mg/1; Doxylamine Succinate 6.25 mg/1 Capsule, Liquid Filled	HyVee Inc	OTC MONOGRAPH DRUG
50844-547	Kit	L.N.K. International, Inc.	OTC MONOGRAPH DRUG
50844-640	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	L.N.K. International, Inc.	OTC MONOGRAPH DRUG
71141-179	Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Solution	Lidl US LLC	OTC MONOGRAPH DRUG
71141-180	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	Lidl US LLC	OTC MONOGRAPH DRUG
41250-643	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	Meijer Distribution Inc	OTC MONOGRAPH DRUG
79481-6170	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	Meijer Distribution, Inc.	OTC MONOGRAPH DRUG
79481-5030	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	Meijer Distribution, Inc.	OTC MONOGRAPH DRUG
56062-198	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated	PUBLIX SUPER MARKETS INC	OTC MONOGRAPH DRUG
63868-140	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid	QUALITY CHOICE (Chain Drug Marketing Association)	OTC MONOGRAPH DRUG
63868-234	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid	QUALITY CHOICE (Chain Drug Marketing Association)	OTC MONOGRAPH DRUG
63868-736	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled	QUALITY CHOICE (Chain Drug Marketing Association)	OTC MONOGRAPH DRUG
11822-6179	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	Rite Aid Corporation	OTC MONOGRAPH DRUG
11822-5034	Kit	Rite Aid Corporation	OTC MONOGRAPH DRUG
11822-5031	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	Rite Aid Corporation	OTC MONOGRAPH DRUG
21130-650	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled	Safeway, Inc.	OTC MONOGRAPH DRUG
21130-598	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled	Safeway, Inc.	OTC MONOGRAPH DRUG
49035-053	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	Wal-Mart Stores Inc	OTC MONOGRAPH DRUG
0363-0566	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	Walgreen Company	OTC MONOGRAPH DRUG
0363-9913	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	Walgreen Company	OTC MONOGRAPH DRUG
0363-9912	Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Solution	Walgreen Company	OTC MONOGRAPH DRUG
0363-9042	Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL; Phenylephrine… Solution	Walgreen Company	OTC MONOGRAPH DRUG
0363-0401	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution	Walgreen Company	OTC MONOGRAPH DRUG
0363-0640	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	Walgreen Company	OTC MONOGRAPH DRUG
0363-8078	Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Phenylephrine Hydrochloride 10 mg/20mL;… Solution	Walgreen Company	OTC MONOGRAPH DRUG
0363-8063	Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Triprolidine Hydrochloride 2.5 mg/20mL Solution	Walgreen Company	OTC MONOGRAPH DRUG
0363-6406	Kit	Walgreen Company	OTC MONOGRAPH DRUG
0363-4278	Kit	Walgreen Company	OTC MONOGRAPH DRUG
0363-0666	Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Solution	Walgreen Company	OTC MONOGRAPH DRUG
0363-1213	Kit	Walgreen Company	OTC MONOGRAPH DRUG
0363-3430	Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid	Walgreens	OTC MONOGRAPH DRUG
0363-9011	Kit	Walgreens	OTC MONOGRAPH DRUG
0363-9012	Kit	Walgreens	OTC MONOGRAPH DRUG
79903-119	Acetaminophen 650 mg/20mL; Dextromethorphan Hydrobromide 20 mg/20mL; Triprolidine Hydrochloride 2.5 mg/20mL Solution	WALMART INC.	OTC MONOGRAPH DRUG
79903-218	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated	WALMART INC.	OTC MONOGRAPH DRUG
79903-236	Kit	WALMART INC.	OTC MONOGRAPH DRUG
79903-432	Kit	WALMART INC.	OTC MONOGRAPH DRUG
79903-433	Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1 Tablet, Film Coated	WALMART INC.	OTC MONOGRAPH DRUG
51393-5000	European Elderberry 89 [hp_C]/100mL; Berberis Vulgaris Root 34 [hp_C]/100mL; Solidago Canadensis Flowering Top 21… Solution/ Drops	Forces of Nature	UNAPPROVED HOMEOPATHIC

Frequently asked questions

What is Cold and Flu used for?

Who makes Cold and Flu?

Cold and Flu is listed by 23 labelers in the FDA NDC directory, including ARMY AND AIR FORCE EXCHANGE SERVICE, Best Choice (Valu Merchandisers Company), Bi-Mart, Cardinal Health 110, LLC. DBA Leader.