DailyMed - AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

NDC Code(s): 69729-802-10
Packager: OPMX LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 31, 2025

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Active ingredient
Active ingredients (in each Softgel)Purposes - Acetaminophen 325 mgPain reliever/Fever reducer - Dextromethorphan HBr 10 mgCough suppressant - Phenylephrine HCl 5mgNasal ...
Active ingredients (in each Softgel) Purposes

Acetaminophen 325 mg Pain reliever/Fever reducer

Dextromethorphan HBr 10 mg Cough suppressant

Phenylephrine HCl 5mg Nasal descongestant
Uses

Temporarily relieves common cold/flu symptoms:
- Nasal congestion
- Cough due to minor throat & bronchial irritation
- Sore throat
- Headache
- Minor aches and pains
- Fever
Uses
- Pain reliever/Fever reducer
- Cough suppressant
- Nasal descongestant
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: More than 4 doses in 24 hrs, which is the maximum daily amount for this product. With other drugs ...
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- More than 4 doses in 24 hrs, which is the maximum daily amount for this product.
- With other drugs containing acetaminophen.
- 3 or more alcoholic drinks daily while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddening
- Blisters
- Rash
- If a skin reactions occurs, stop use and seek medical help right away
Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompained 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
- Hear disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
- Cough that occurs with too mcuh plegm (mucus)
- Persistent or chronic cough occurs with smoking, asthma, chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if you are:

Taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.
Stop use and ask a doctor if
- You get nervous, dizzy or sleepless
- Symptoms get worse or last more than 5 days (children) or 7 days (adults)
- 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

If pregnant or breast-feeding

ask a health professional before use.

Overdose warning:

Taking more than directed can cause serious health problems. 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 dot notice any signs or symptoms.

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Directions
Take only as directed. Do not exceed 4 doses per 24 hours. Adults & children 12 yrs & over2 softgels with water every 4 hrs - Children 4 to under 12 yrsAsk a doctor - Children under 4 yrsDo ...
- Take only as directed.
- Do not exceed 4 doses per 24 hours.
Adults & children 12 yrs & over 2 softgels with water every 4 hrs

Children 4 to under 12 yrs Ask a doctor

Children under 4 yrs Do not use

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Other information
Store at room temperature.
- Store at room temperature.
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Inactive ingredients
FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.

FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.
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Questions?
Call toll free 619-600-5632 - Monday through Friday 9AM - 5PM EST

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST
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PRINCIPAL DISPLAY PANEL
NDC 69729-802-10 - AGRIFEN - Acetaminophen 325 mg - Dextomethorphan HBr 10 mg - Phenylephrine HCl 5 mg - Dolor de Cabeza - Headache - Congestión Nasal - Nassal Congestion - Ojos llorosos - Itchi, Watery ...

NDC 69729-802-10

AGRIFEN

Acetaminophen 325 mg

Dextomethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Dolor de Cabeza

Headache

Congestión Nasal

Nassal Congestion

Ojos llorosos

Itchi, Watery eyes

Escurrimiento Nasal y Estornudos

Runny Nose & Sneezing

10 Soft Gels

Exclusively distributes by:

OPMX

Chula Vista, CA 91910

Phine: 619-600-5632

TAMPER EVIDENT:

Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
SOFTECH PHARMA PRIVATE LIMITED		677111277	manufacture(69729-802) , label(69729-802) , pack(69729-802)

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	RxCUI	RxNorm NAME	RxTTY
1	1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN
2	1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD
3	1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY

Label: AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

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Drug Label Info

Safety

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Drug Label Information

Uses

Uses

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are:

When using this product,

Stop use and ask a doctor if

Keep out of reach of children

If pregnant or breast-feeding

Overdose warning:

Find additional resources

Safety

Related Resources

More Info on this Drug

Active ingredients (in each Softgel)	Purposes
Acetaminophen 325 mg	Pain reliever/Fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Phenylephrine HCl 5mg	Nasal descongestant

Adults & children 12 yrs & over	2 softgels with water every 4 hrs
Children 4 to under 12 yrs	Ask a doctor
Children under 4 yrs	Do not use

Label: AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Uses

Uses

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are:

When using this product,

Stop use and ask a doctor if

Keep out of reach of children

If pregnant or breast-feeding

Overdose warning:

Find additional resources

Safety

Related Resources

More Info on this Drug

AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Number of versions: 1

AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

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AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.