DrugCite

NON ASPIRIN PM EXTRA STRENGTH - acetaminophen and diphenhydramine hydrochloride tablet, coated 
Chain Drug Consortium, LLC (Premier Value)

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 products 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

  • 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

Premier Value Non Aspirin PM Geltabs

Acetaminophen PM geltabs


NON ASPIRIN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 68016-188
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  
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
Color BLUE, WHITE Score no score
Shape ROUND Size 13mm
Flavor Imprint Code BPI;50
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 68016-188-50 1 BOTTLE In 1 CARTON contains a BOTTLE
1 50 TABLET In 1 BOTTLE This package is contained within the CARTON (68016-188-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part338 10/24/2012

Labeler - Chain Drug Consortium, LLC (Premier Value) (101668460)
Revised: 11/2012Chain Drug Consortium, LLC (Premier Value)