Non-drowsy Daytime

Non-drowsy Daytime
SPL v5
SPL
SPL Set ID e2657c3d-4767-41b5-9f40-7961b8af9b56
Route
ORAL
Published
Effective Date 2022-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Gelatin Glycerin Potassium Aluminum Disilicate Polyethylene Glycol, Unspecified Povidone Propylene Glycol Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 105 Shape: oval Color: orange Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-20

Description

Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

Uses

• temporarily relieves these symptoms due to a cold or flu:

• minor aches and pains

• headache

• cough

• sore throat

• nasal and sinus congestion

• temporarily reduces fever

Carton

TopCare health

NDC 36800-720-24

COMPARE TO ALKA-SELTZER® PLUS®

MAXIMUM STRENGTH DAYTIME COLD & FLU

POWERMAXTM GELS ACTIVE INGREDIENTS*



NON-DROWSY DAYTIME



Cold & Flu Max Softgels

MAXIMUM STRENGTH

PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN

COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

NASAL DECONGESTANT - PHENYLEPHRINE HCl



RELIEVES:

• Nasal Congestion

• Cough

• Headache & Body Ache

• Sore Throat

• Sinus Pressure

•Smaller Capsule •Same Strength

24SOFTGELS**

**Liquid-Filled Capsules

minis

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

Directions

• do not take more than the recommended dose

• adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.

• 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 or pharmacist before taking this product.

• if you have ever had an allergic reaction to this product or any of its ingredients

• in children under 12 years of age

Allergy Alert:

Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening

• blisters

• rash n hives

• facial swelling

• asthma (wheezing)

• shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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

Other Information

• store at room temperature. Avoid temperatures above 25°C (77°F).

Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, pearlin silver, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide

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.

Questions Or Comments?

1-888-423-0139

Stop Use and Ask A Doctor If

• pain, cough, or nasal congestion 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.

• nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding, ask a health professional before use.

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.

Ask A Doctor Before Use If You Have

• liver disease n heart disease n high blood pressure

• thyroid disease n diabetes

• cough with excessive phlegm (mucus)

• difficulty in urination due to enlargement of the prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

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


Structured Label Content

Uses

• temporarily relieves these symptoms due to a cold or flu:

• minor aches and pains

• headache

• cough

• sore throat

• nasal and sinus congestion

• temporarily reduces fever

Carton

TopCare health

NDC 36800-720-24

COMPARE TO ALKA-SELTZER® PLUS®

MAXIMUM STRENGTH DAYTIME COLD & FLU

POWERMAXTM GELS ACTIVE INGREDIENTS*



NON-DROWSY DAYTIME



Cold & Flu Max Softgels

MAXIMUM STRENGTH

PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN

COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

NASAL DECONGESTANT - PHENYLEPHRINE HCl



RELIEVES:

• Nasal Congestion

• Cough

• Headache & Body Ache

• Sore Throat

• Sinus Pressure

•Smaller Capsule •Same Strength

24SOFTGELS**

**Liquid-Filled Capsules

minis

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Warnings

Directions

• do not take more than the recommended dose

• adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.

• 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 or pharmacist before taking this product.

• if you have ever had an allergic reaction to this product or any of its ingredients

• in children under 12 years of age

Allergy Alert: (Allergy alert:)

Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening

• blisters

• rash n hives

• facial swelling

• asthma (wheezing)

• shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Liver Warning: (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

Other Information (Other information)

• store at room temperature. Avoid temperatures above 25°C (77°F).

Inactive Ingredients (Inactive ingredients)

FD&C yellow #6, gelatin, glycerin, pearlin silver, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide

Sore Throat Warning: (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.

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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

• 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.

• nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding, ask a health professional before use.

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• liver disease n heart disease n high blood pressure

• thyroid disease n diabetes

• cough with excessive phlegm (mucus)

• difficulty in urination due to enlargement of the prostate gland

• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 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

When using this product do not exceed recommended dosage


Advanced Ingredient Data


Raw Label Data

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