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Acetaminophen Diphenhydramine HCl

Medically reviewed on November 30, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Pharmacy Value Alliance, LLC
NDC Code: 68016-659

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Acetaminophen, USP 500mg/Diphenhydramine HCl 25mg Gelcaps

Active ingredient

(in each gelcap)

Acetaminophen, USP 500 mg

Diphenhydramine HCl 25 mg

Purpose

Pain reliever

Nighttime sleep aid

Uses

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

Warnings

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

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.

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

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

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.

Keep out of the reach of children

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

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

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

ACETAMINOPHEN DIPHENHYDRAMINE HCL 
acetaminophen diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-659
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
FD&C RED NO. 40 
HYPROMELLOSES 
MICROCRYSTALLINE CELLULOSE 
BUTYL ALCOHOL 
STARCH, PREGELATINIZED CORN 
PROPYLENE GLYCOL 
TITANIUM DIOXIDE 
TRIACETIN 
SHELLAC 
STEARIC ACID 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
GELATIN 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
ISOPROPYL ALCOHOL 
POVIDONE 
Product Characteristics
Colorgray (Encapsulated with dark blue opaque and light blue opaque hard gelatin shells) Scoreno score
ShapeOVALSize21mm
FlavorImprint CodeG3
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-659-0550 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/25/2016
Labeler - Pharmacy Value Alliance, LLC (101668460)

 
Pharmacy Value Alliance, LLC

← See all Acetaminophen Diphenhydramine HCl brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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