Drug Facts
92d34aa9-fe16-4c9c-80dc-c27834eb45bf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg
Purpose
Pain reliever/fever reducer Cough suppressant Nasal decongestant
How Supplied
Product: 50090-6476 NDC: 50090-6476-0 1 CAPSULE, LIQUID FILLED in a BLISTER PACK / 16 in a CARTON
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
How Supplied
Product: 50090-6476
NDC: 50090-6476-0 1 CAPSULE, LIQUID FILLED in a BLISTER PACK / 16 in a CARTON
Description
Acetaminophen 325 mg Dextromethoprhan HBr 10 mg Phenlyephrine HCl 5 mg
Uses
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- fever
- 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 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.
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
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.
Other Information
- store at between 15-30ºC (59-86ºF)
- avoid excessive heat
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 Or Comments?
Call 1-800-616-2471
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.
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)
Active Ingredients (in Each Softgel)
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 mg
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Cold and Flu Relief Daytime Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl
Structured Label Content
Uses
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- fever
- cough due to minor throat and bronchial irritation
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
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.
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
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.
How Supplied (HOW SUPPLIED)
Product: 50090-6476
NDC: 50090-6476-0 1 CAPSULE, LIQUID FILLED in a BLISTER PACK / 16 in a CARTON
Other Information (Other information)
- store at between 15-30ºC (59-86ºF)
- avoid excessive heat
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 Or Comments? (Questions or comments?)
Call 1-800-616-2471
When Using This Product, (When using this product,)
do not exceed recommended dosage.
Stop Use and Ask A Doctor If (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, (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
- 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)
Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))
Acetaminophen 325 mg
Dextromethoprhan HBr 10 mg
Phenlyephrine HCl 5 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.
Cold and Flu Relief Daytime Acetaminohpen, Dextromethorphan Hbr, Phenylephrine Hcl (COLD AND FLU RELIEF DAYTIME- acetaminohpen, dextromethorphan hbr, phenylephrine hcl)
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Source: dailymed · Ingested: 2026-02-15T12:00:47.259850 · Updated: 2026-03-14T23:01:09.685872