Rapid Release Gelcaps

Rapid Release Gelcaps
SPL v12
SPL
SPL Set ID b375de90-25c7-aa55-e053-2995a90a3cf8
Route
ORAL
Published
Effective Date 2021-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Hydroxypropyl Cellulose, Unspecified Ferrosoferric Oxide Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Hydroxymethyl Cellulose Shellac Titanium Dioxide Ferric Oxide Yellow Fd&c Blue No. 1 D&c Red No. 33 Hypromellose 2208 (100 Mpa.s) Ferric Oxide Red Butyl Alcohol Propylene Glycol Polyethylene Glycol, Unspecified Ammonia Povidone Starch, Corn Stearic Acid Croscarmellose Sodium Isopropyl Alcohol Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G1 Shape: oval Color: gray Size: 19 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-24

Description

​Pain reliever/fever reducer

Purpose

​Pain reliever/fever reducer


Medication Information

Purpose

​Pain reliever/fever reducer

Description

​Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ toothache

■ he common cold

■ premenstrual and menstrual cramps

■ temporarily reduces fever

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.

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 Centerright away (1-800- 222-1222). 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.

Principal Display Panel

Principal Display Panel

Questions Or Comments ?

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

Stop Use and Ask A 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.

Keep Out of the Reach of Children.

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.

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.


Structured Label Content

Uses

■ temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ toothache

■ he common cold

■ premenstrual and menstrual cramps

■ temporarily reduces fever

Purpose

​Pain reliever/fever reducer

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 (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: (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 (Overdose warning)

In case of accidental overdose, get medical help or contact a Poison Control Centerright away (1-800- 222-1222). 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

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.

Principal Display Panel (Principal DIsplay Panel)

Principal Display Panel

Questions Or Comments ? (Questions or comments ?)

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

Stop Use and Ask A Doctor If (Stop use and ask a 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.

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

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.

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.


Advanced Ingredient Data


Raw Label Data

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