DrugCite

NON-ASPIRIN PM EXTRA STRENGTH - acetaminophen and diphenhydramine hydrochloride tablet, coated 
Freds Inc

DRUG FACTS

Active ingredients (in each geltab)

Acetaminophen 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

Do not use

  • with other products 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

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.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 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 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
  • children under 12 years: do not use

Other information

  • store at room temperature 15º-30ºC (59º-86ºF)
  • avoid high humidity and excessive heat

Inactive ingredients

corn starch, croscarmellose sodium*, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium starch glycolate*, stearic acid, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

Non-Aspirin PM

Acetaminophen, 500 mg

Diphenhydramine HCl, 25 mg

Extra Strength Pain Reliever/Nighttime Sleep-Aid

Geltabs

Compare to the active ingredients in Extra Strength Tylenol® PM**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: fred's Inc.

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.fredsinc.com

Product Label

Acetaminophen 500 mg; Diphenhydramine HCl 25 mg

Non-Aspirin PM Geltab


NON-ASPIRIN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55315-229
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
D&C RED NO. 27  
FD&C BLUE NO. 1  
GELATIN  
GLYCERIN  
HYPROMELLOSES  
MALTODEXTRIN  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOLS  
POVIDONES  
WATER  
SILICON DIOXIDE  
STEARIC ACID  
TITANIUM DIOXIDE  
CROSCARMELLOSE SODIUM  
SODIUM STARCH GLYCOLATE TYPE A CORN  
Product Characteristics
Color WHITE, BLUE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code BPI50
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 55315-229-50 1 BOTTLE In 1 BOX contains a BOTTLE, PLASTIC
1 50 CAPSULE In 1 BOTTLE, PLASTIC This package is contained within the BOX (55315-229-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 07/08/2022

Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)
Revised: 03/2013Freds Inc