Cold Relief
Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl · Kit · Oral
Active ingredient
Active ingredients (in each caplet) (Daytime Cold Multi-Symptom) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Active ingredients (in each caplet) (Nighttime Cold Multi-Symptom) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant Purpose Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant
Uses
Uses temporarily relieves these common cold and flu symptoms: cough headache sore throat nasal congestion minor aches and pains sinus congestion and pressure sneezing and runny nose (Nighttime only) helps clear nasal passages promotes nasal and sinus drainage relieves cough to help you sleep temporarily reduces fever
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: skin reddening blisters rash 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 diabetes liver disease high blood pressure heart disease glaucoma (Nighttime only) cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema difficulty in urination due to enlargement of the prostate gland thyroid disease a breathing problem such as emphysema or chronic bronchitis (Nighttime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only) When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) 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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 take DAYTIME and NIGHTTIME products at the same time.
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 diabetes liver disease high blood pressure heart disease glaucoma (Nighttime only) cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema difficulty in urination due to enlargement of the prostate gland thyroid disease a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (Nighttime only)
When using this product
When using this product do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
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 new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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. Do not take DAYTIME and NIGHTTIME products at the same time.
Directions
Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Other information
Other information each caplet contains: sodium 3 mg (Nighttime only) 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 (Daytime only) corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide Inactive ingredients (Nighttime only) corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions?
Questions or comments? 1-800-426-9391
Label text from the FDA structured product label by L.N.K. International, Inc. (revised Aug 6, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 2 products
- Dextromethorphan Hydrobromide in 2 products
- Phenylephrine Hydrochloride in 2 products
- Pelargonium Sidoides Root in 1 product
Cold Relief NDC products (5)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70000-0652 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Cardinal Health 110, LLC. DBA Leader | OTC MONOGRAPH DRUG |
| 50844-529 | Kit | L.N.K. International, Inc. | OTC MONOGRAPH DRUG |
| 41163-907 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | United Natural Foods, Inc. dba UNFI | OTC MONOGRAPH DRUG |
| 53499-7270 | Pelargonium Sidoides Root 1 [hp_X]/30mL Liquid | Schwabe North America | UNAPPROVED HOMEOPATHIC |
| 53499-2060 | Kit | Schwabe North America, Inc. | UNAPPROVED HOMEOPATHIC |
Frequently asked questions
What is Cold Relief used for?
Uses temporarily relieves these common cold and flu symptoms: cough headache sore throat nasal congestion minor aches and pains sinus congestion and pressure sneezing and runny nose (Nighttime only) helps clear nasal passages promotes nasal and sinus drainage relieves cough to help you sleep temporarily reduces fever
Who makes Cold Relief?
Cold Relief is listed by 5 labelers in the FDA NDC directory, including Cardinal Health 110, LLC. DBA Leader, L.N.K. International, Inc., United Natural Foods, Inc. dba UNFI, Schwabe North America.