Cold and Flu Relief
Liquid · Oral, Sublingual
Active ingredient
Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant
Uses
Uses temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever sinus pressure cough due to minor throat and bronchial irritation
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. Ask a doctor before use if you have liver disease diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) 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 pain, cough, or nasal congestion gets worse or lasts more than 7 days nervousness, dizziness, or sleeplessness occur 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. Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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.
Ask a doctor before use
Ask a doctor before use if you have liver disease diabetes heart disease thyroid disease high blood pressure trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)
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 pain, cough, or nasal congestion gets worse or lasts more than 7 days nervousness, dizziness, or sleeplessness occur 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. Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 (see Overdose warning) do not take more than 4 doses in 24 hours adults and children 12 years and over: take 2 softgels with water every 4 hours swallow whole; do not crush, chew, or dissolve children under 12 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Inactive ingredients
Inactive ingredients FD&C red #40, FD&C yellow#6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
Questions?
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Label text from the FDA structured product label by CARDINAL HEALTH 110, LLC. DBA LEADER 70000 (revised Sep 9, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 23 products
- Dextromethorphan Hydrobromide in 23 products
- Phenylephrine Hydrochloride in 15 products
- Doxylamine Succinate in 8 products
- Guaifenesin in 3 products
- Gelsemium Sempervirens Root in 3 products
- Onion in 2 products
- Lobaria Pulmonaria in 2 products
- Antimony Potassium Tartrate in 1 product
- Arnica Montana Whole in 1 product
- Solanum Dulcamara Whole in 1 product
- Eupatorium Perfoliatum Flowering Top in 1 product
Cold and Flu Relief NDC products (26)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70000-0752 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | OTC MONOGRAPH DRUG |
| 70000-0515 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | OTC MONOGRAPH DRUG |
| 68016-797 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled | Chain Drug Consortium, LLC | OTC MONOGRAPH DRUG |
| 55910-910 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 15 mg/1; Doxylamine Succinate 6.25 mg/1 Capsule, Liquid Filled | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | OTC MONOGRAPH DRUG |
| 55910-599 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 15 mg/1; Doxylamine Succinate 6.25 mg/1 Capsule, Liquid Filled | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | OTC MONOGRAPH DRUG |
| 55910-366 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Liquid | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | OTC MONOGRAPH DRUG |
| 55910-149 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 15 mg/1; Doxylamine Succinate 6.25 mg/1 Capsule, Liquid Filled | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | OTC MONOGRAPH DRUG |
| 55319-646 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Liquid | Family Dollar (FAMILY WELLNESS) | OTC MONOGRAPH DRUG |
| 37808-848 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled | H E B | OTC MONOGRAPH DRUG |
| 37808-864 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled | H E B | OTC MONOGRAPH DRUG |
| 0904-6995 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Phenylephrine Hydrochloride 5 mg/1 Capsule, Liquid Filled | Major Pharmaceuticals | OTC MONOGRAPH DRUG |
| 83324-168 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Liquid | QUALITY CHOICE (Chain Drug Marketing Association) | OTC MONOGRAPH DRUG |
| 11822-5832 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid | Rite Aid Corporation | OTC MONOGRAPH DRUG |
| 11822-0640 | 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 |
| 21130-603 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Solution | Safeway | OTC MONOGRAPH DRUG |
| 21130-436 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Guaifenesin 200 mg/15mL; Phenylephrine… Solution | Safeway | OTC MONOGRAPH DRUG |
| 21130-849 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 15 mg/1; Doxylamine Succinate 6.25 mg/1 Capsule, Liquid Filled | Safeway, Inc. | OTC MONOGRAPH DRUG |
| 0363-9974 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Liquid | Walgreens | OTC MONOGRAPH DRUG |
| 67091-258 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid | WinCo Foods, LLC | OTC MONOGRAPH DRUG |
| 67091-260 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 30 mg/30mL; Doxylamine Succinate 12.5 mg/30mL Liquid | WinCo Foods, LLC | OTC MONOGRAPH DRUG |
| 67091-287 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Liquid | WinCo Foods, LLC | OTC MONOGRAPH DRUG |
| 67091-288 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | WinCo Foods, LLC | OTC MONOGRAPH DRUG |
| 67091-471 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Phenylephrine Hydrochloride 5 mg/15mL Liquid | WinCo Foods, LLC | OTC MONOGRAPH DRUG |
| 71409-303 | Gelsemium Sempervirens Root 18 [hp_X]/1; Atropa Belladonna 8 [hp_X]/1; Eupatorium Cannabinum Whole 8 [hp_X]/1; Allium… Pellet | Clineva Management Services, LLC | UNAPPROVED HOMEOPATHIC |
| 61096-1002 | Onion 30 [hp_C]/41mL; Antimony Potassium Tartrate 200 [hp_C]/41mL; Arnica Montana Whole 4 [hp_X]/41mL; Baptisia… Liquid | Eight and Company L.L.C | UNAPPROVED HOMEOPATHIC |
| 70163-0040 | Aconitum Napellus Whole 3 [hp_X]/mL; Onion 6 [hp_X]/mL; Echinacea Angustifolia Whole 3 [hp_X]/mL; Euphrasia Stricta 6… Liquid | NaturalCare | UNAPPROVED HOMEOPATHIC |
Frequently asked questions
What is Cold and Flu Relief used for?
Uses temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever sinus pressure cough due to minor throat and bronchial irritation
Who makes Cold and Flu Relief?
Cold and Flu Relief is listed by 15 labelers in the FDA NDC directory, including CARDINAL HEALTH 110, LLC. DBA LEADER 70000, Chain Drug Consortium, LLC, Dolgencorp, Inc. (DOLLAR GENERAL & REXALL), Family Dollar (FAMILY WELLNESS).