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Acetaminophen Diphenhydramine HCl

Medically reviewed on Jul 17, 2017

Dosage form: capsule
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: FREDS, INC
NDC Code: 55315-988

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.

EXTRA STRENGTH
PAIN RELIEF PM

Pain Reliever/Nighttime Sleep Aid
Acetaminophen, USP 500 mg each/
Diphenhydramine HCl 25 mg each

Active ingredient

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

Purposes

Pain reliever
Nighttime sleep aid

Uses

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

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

■ 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.

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

EXTRA STRENGTH
PAIN RELIEF PM

Pain Reliever/Nighttime Sleep Aid
Acetaminophen, USP 500 mg each/
Diphenhydramine HCl 25 mg each
Aspirin Free

Non-Habit Forming
24 GELCAPS

ACETAMINOPHEN DIPHENHYDRAMINE HCL 
acetaminophen diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-988
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
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 
Product Characteristics
Colorgray (with dark blue opaque and light blue opaque hard gelatin shells) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeG3
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-988-2424 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/17/2017
Labeler - FREDS, INC (005866116)

 
FREDS, INC

← 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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