Extra Strength

Extra Strength
SPL v1
SPL
SPL Set ID 5486d426-4709-0bed-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Hydroxypropyl Cellulose, Unspecified Gelatin Isopropyl Alcohol Microcrystalline Cellulose Povidone K30 Propylene Glycol Shellac Stearic Acid Titanium Dioxide Triacetin Fd&c Yellow No. 6 Silicon Dioxide Croscarmellose Sodium Fd&c Red No. 40 Hypromelloses Butyl Alcohol Fd&c Blue No. 2 Starch, Pregelatinized Corn

Identifiers & Packaging

Pill Appearance
Imprint: G3 Shape: capsule Color: gray Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-17

Description

Active ingredient Purpose (in each gelcap) Acetaminophen, USP 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever Nighttime sleep aid

Description

Active ingredient Purpose (in each gelcap) Acetaminophen, USP 500 mg Diphenhydramine HCl 25 mg

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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 at bedtime

■ do not take more than 2 gelcaps of this product in 24 hours

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.

■ with any other product containing diphenhydramine, even one used on skin

■ in children under 12 years of age

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

Allergy Alert

acetaminophen may cause severe skin reaction. 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

Extra Strength

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 right 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

Active Ingredient

Active ingredient Purpose

(in each gelcap)

Acetaminophen, USP 500 mg

Diphenhydramine HCl 25 mg

Other Information

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

■ see end panel for lot number and expiration date

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C red #40, FD&C Yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

When Using This Product

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

Stop Use and Ask A Doctor If

■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present

■ new symptoms occur

These could be signs of a serious condition.

If Pregnant Or Breast Feeding

ask a health professional before use.

Ask A Doctor Before Use If You Have

■ liver disease

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers


Structured Label Content

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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 at bedtime

■ do not take more than 2 gelcaps of this product in 24 hours

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.

■ with any other product containing diphenhydramine, even one used on skin

■ in children under 12 years of age

■ 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 reaction. 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

Extra Strength (EXTRA STRENGTH)

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 right 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

Active Ingredient (Active ingredient)

Active ingredient Purpose

(in each gelcap)

Acetaminophen, USP 500 mg

Diphenhydramine HCl 25 mg

Other Information (Other information)

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

■ see end panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C red #40, FD&C Yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.

Questions Or Comments? (Questions or comments?)

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

When Using This Product (When using this product)

■ taking the blood thinning drug warfarin

■ taking sedatives or tranquilizers

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

■ sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present

■ new symptoms occur

These could be signs of a serious condition.

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

ask a health professional before use.

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

■ liver disease

■ a breathing problem such as emphysema or chronic bronchitis

■ trouble urinating due to an enlarged prostate gland

■ glaucoma

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

■ taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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