Combo Pack

Combo Pack
SPL v5
SPL
SPL Set ID b3763182-2428-155a-e053-2995a90ab578
Route
ORAL
Published
Effective Date 2023-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Triacetin Hydroxypropyl Cellulose, Unspecified Fd&c Blue No. 2 D&c Red No. 28 Gelatin Butyl Alcohol Shellac Stearic Acid Microcrystalline Cellulose Ammonia Fd&c Red No. 40 Polyethylene Glycol, Unspecified Ferric Oxide Red Starch, Corn Propylene Glycol D&c Yellow No. 10 Croscarmellose Sodium D&c Red No. 33 Fd&c Blue No. 1 Titanium Dioxide Ferrosoferric Oxide Silicon Dioxide Fd&c Yellow No. 6 Hypromellose, Unspecified Isopropyl Alcohol Povidone Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: G1;G3 Shape: oval Color: gray Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-03

Description

Acetaminophen USP, 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen USP, 500 mg

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Purposes

Pain reliever

Nighttime sleep aid

Directions

■ do not take more than directed (see overdose warning)

adults and children 12 years and over

■ take 2 gelcaps every 6 hours while symptoms last

■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor

■ do not take more than 10 days unless directed by a doctor

children under 12 years

■ ask a doctor

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

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.

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.

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

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

Overdose Warning

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Overdose Warning

Taking more than the recommended dose (overdose) may 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.

Other Information

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature

■ avoid high humidity

■ see end panel for lot number and expiration date

Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red#33, FD&C blue#1, FD&C red#40, FD&C yellow#6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Principal Display Panel

When Using This Product

■ drowsiness will occur

■ avoid alcoholic drinks

■ do not drive a motor vehicle or operate machinery

Stop Use and Ask Doctor If

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding

ask a health professional before use.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of the Reach of Children.

Keep out of the reach of children.

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Acetaminophen Gelcaps Active Ingredient (in Each Gelcap)

Acetaminophen USP, 500 mg

Acetaminophen Pm Gelcaps Active Ingredient (in Each Gelcap)

Acetaminophen USP, 500 mg

Diphenhydramine HCl USP, 25 mg


Structured Label Content

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Purpose

Pain reliever/fever reducer

Purposes

Pain reliever

Nighttime sleep aid

Directions

■ do not take more than directed (see overdose warning)

adults and children 12 years and over

■ take 2 gelcaps every 6 hours while symptoms last

■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor

■ do not take more than 10 days unless directed by a doctor

children under 12 years

■ ask a doctor

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

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.

Allergy Alert (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.

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

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

Overdose Warning

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may 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.

Other Information (Other information)

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature

■ avoid high humidity

■ see end panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red#33, FD&C blue#1, FD&C red#40, FD&C yellow#6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

Principal Display Panel

When Using This Product (When using this product)

■ drowsiness will occur

■ avoid alcoholic drinks

■ do not drive a motor vehicle or operate machinery

Stop Use and Ask Doctor If (Stop use and ask doctor if)

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

Keep out of the reach of children.

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

liver disease

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.

Acetaminophen Gelcaps Active Ingredient (in Each Gelcap) (Acetaminophen Gelcaps Active Ingredient (in each Gelcap))

Acetaminophen USP, 500 mg

Acetaminophen Pm Gelcaps Active Ingredient (in Each Gelcap) (Acetaminophen PM Gelcaps Active ingredient (in each gelcap))

Acetaminophen USP, 500 mg

Diphenhydramine HCl USP, 25 mg


Advanced Ingredient Data


Raw Label Data

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