Drug Facts
f81efbf4-204b-45be-ae32-910d9e4ae4aa
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg
Purpose
Pain reliever/Fever Reduce r Cough suppressant Antihistamine
Medication Information
Purpose
Pain reliever/Fever Reducer
Cough suppressant
Antihistamine
Description
Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
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 everyday 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 more than 2 days, is accompanied or followed by fever, headache rash, nausea, or vomiting, consult a doctor promptly.
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 6 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: 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 of pharmacist before taking this product.
Package Label
Other Information
- store between 15º-30ºC (59º-86ºF)
- avoid excessive heat
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
compare to the active ingredients in Vicks® Nyquil™ Cold & Flu LiquiCaps™†
nighttime
cold and flu relief
acetaminophen 325 mg
pain reliever/fever reducer
dextromethorphan HBr 15 mg,
cough suppressant
doxylamine succinate 6.25 mg
antihistamine
relieves: aches, fever, sore throat, cough, runny nose, and sneezing
alcohol-free
softgels**
(**liquid-filled capsules)
†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil™, and LiquiCaps™ are registered trademark of the Procter & Gamble Company
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
- pain 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.
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.
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Structured Label Content
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
Purpose
Pain reliever/Fever Reducer
Cough suppressant
Antihistamine
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 everyday 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 more than 2 days, is accompanied or followed by fever, headache rash, nausea, or vomiting, consult a doctor promptly.
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 6 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
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 of pharmacist before taking this product.
Package Label
Other Information (Other information)
- store between 15º-30ºC (59º-86ºF)
- avoid excessive heat
Inactive Ingredients (Inactive ingredients)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
Questions Or Comments? (Questions or comments?)
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
compare to the active ingredients in Vicks® Nyquil™ Cold & Flu LiquiCaps™†
nighttime
cold and flu relief
acetaminophen 325 mg
pain reliever/fever reducer
dextromethorphan HBr 15 mg,
cough suppressant
doxylamine succinate 6.25 mg
antihistamine
relieves: aches, fever, sore throat, cough, runny nose, and sneezing
alcohol-free
softgels**
(**liquid-filled capsules)
†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil™, and LiquiCaps™ are registered trademark of the Procter & Gamble Company
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
When Using This Product (When using this product)
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- pain 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, (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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:07.011143 · Updated: 2026-03-14T23:12:15.627416