Acetaminophen 325 Mg, Dextromethorphan Hbr 10mg And Phenylephrine Hcl 5 Mg Softgelatin Capsules (day Time - Yellow)
3afc88c7-388a-dbd9-e063-6294a90a4faf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg
Purpose
Pain reliever/fever reducer Cough suppressant Nasal decongestant
Medication Information
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Description
Acetaminophen USP 325 mg Dextromethorphan HBr USP 10 mg Phenylephrine HCl USP 5 mg
Uses
Temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Section 51945-4
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product
- 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
- take only as directed
- do not exceed 8 Softgels per 24 hrs
| adults & children 12 years & over | 2 Softgels with water every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 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 or pharmacist before taking this product.
Other Information
- stored at 15° - 25°C (59° - 77°F)
Inactive Ingredients
D&C yellow no. 10, gelatin, glycerin, polyethylene glycol 400, povidone k 30, propylene glycol, purified water, sorbitol sorbitan solution
When Using This Product,
do not use more than directed.
Stop Use and Ask A Doctor If
- you get nervous, dizzy or sleepless
- 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.
Keep Out of Reach of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as for children even if you do not
notice any signs or symptoms.
If Pregnant Or Breast Feeding,
ask a health professional before use.
Active Ingredient (in Each Softgel)
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 5 mg
Ask A Doctor Before Use If You Have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
Structured Label Content
Uses
Temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
Section 51945-4 (51945-4)
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 8 Softgels in 24 hrs, which is the maximum daily amount for this product
- 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
- take only as directed
- do not exceed 8 Softgels per 24 hrs
| adults & children 12 years & over | 2 Softgels with water every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 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 or pharmacist before taking this product.
Other Information (Other information)
- stored at 15° - 25°C (59° - 77°F)
Inactive Ingredients (Inactive ingredients)
D&C yellow no. 10, gelatin, glycerin, polyethylene glycol 400, povidone k 30, propylene glycol, purified water, sorbitol sorbitan solution
When Using This Product, (When using this product,)
do not use more than directed.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- you get nervous, dizzy or sleepless
- 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.
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.
Quick medical attention is critical for adults as well as for children even if you do not
notice any signs or symptoms.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)
ask a health professional before use.
Active Ingredient (in Each Softgel) (Active ingredient (in each Softgel))
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 5 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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.
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Source: dailymed · Ingested: 2026-02-15T12:07:59.679827 · Updated: 2026-03-14T23:12:06.957806