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NON ASPIRIN PM Extra Strength by Valu Merchandisers Company (Best Choice)

Medically reviewed on December 4, 2017

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Valu Merchandisers Company (Best Choice)
NDC Code: 63941-360

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.

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 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

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- 30o C (59o- 86o F)
  • 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*, stearic acid, titanium dioxide
*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

Compare to active ingredients in extra strength TYLENOL® PM

extra strength

NON-ASPIRIN PM

ACETAMINOPHEN 500 mg/ DIPHENHYDRAMINE HCl 25 mg

For pain with sleeplessness

pain reliever/ nighttime sleep-aid

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

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Label

NON-ASPIRIN PM GELTABS

NON ASPIRIN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-360
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
STARCH, CORN 
CROSCARMELLOSE SODIUM 
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 
ALUMINUM OXIDE 
Product Characteristics
ColorBLUE, WHITEScoreno score
ShapeROUNDSize13mm
FlavorImprint CodeBPI50
Contains    
Packaging
#Item CodePackage Description
1NDC:63941-360-501 BOTTLE (1 BOTTLE) in 1 CARTON
150 TABLET, COATED (50 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33809/10/2012
Labeler - Valu Merchandisers Company (Best Choice) (868703513)
Registrant - P and L Development of New York Corporation (800014821)

 
Valu Merchandisers Company (Best Choice)

← See all NON ASPIRIN PM Extra Strength brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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