Extra Strength

Extra Strength
SPL v5
SPL
SPL Set ID ac0f8d5c-d200-1156-e053-2a95a90aece6
Route
ORAL
Published
Effective Date 2022-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Titanium Dioxide D&c Red No. 28 Butyl Alcohol Fd&c Red No. 40 Propylene Glycol Microcrystalline Cellulose Stearic Acid Silicon Dioxide Triacetin Gelatin Hypromellose 2208 (100 Mpa.s) Starch, Corn Shellac Fd&c Yellow No. 6 D&c Yellow No. 10 Isopropyl Alcohol Povidone K30 Fd&c Blue No. 1 Hydroxypropyl Cellulose, Unspecified Fd&c Blue No. 2 Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: G3 Shape: oval Color: gray Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-12

Description

Acetaminophen, USP 500 mg Diphenhydramine HCl, USP 25 mg

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Purpose

Pain reliever

Nighttime sleep-aid

Description

Acetaminophen, USP 500 mg Diphenhydramine HCl, USP 25 mg

Uses

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

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

Overdose Warning



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

Acetaminophen, USP 500 mg

Diphenhydramine HCl, USP 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 Ingrdients

colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow#10, FD&C blue#1, 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 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 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

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


Structured Label Content

Uses

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

Purpose

Pain reliever

Nighttime sleep-aid

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

Overdose Warning (Overdose warning)



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)

Acetaminophen, USP 500 mg

Diphenhydramine HCl, USP 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 Ingrdients

colloidal silicon dioxide, croscarmellose sodium, D&C red#28, D&C yellow#10, FD&C blue#1, 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 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 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

Do Not Take More Than Directed (see Overdose Warning) (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


Advanced Ingredient Data


Raw Label Data

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