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Acetaminophen PM Extra Strength

Medically reviewed on May 17, 2017

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: EQUALINE (SuperValu)
NDC Code: 41163-228

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 in24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. 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.
  • 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 (1-800-222-1222) 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 between 20-25ºC (68-77ºF)
  • 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 toll free 1-877-932-7948

Principal Display Panel

Compare to Extra Strength Tylenol® PM active ingredients†

Extra Strength

Acetaminophen PM

Acetaminophen 500 mg 

Diphenhydramine HCl 25 mg

Pain reliever/nighttime sleep-aid

Non-habit Forming

Geltabs

†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol® PM.

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN 55344 USA

supervaluprivatebrands.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Product Label

EQUALINE Extra Strength Acetaminophen PM

ACETAMINOPHEN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-228
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 
D&C RED NO. 27 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
HYPROMELLOSES 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
WATER 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
CROSCARMELLOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A CORN 
ALUMINUM OXIDE 
Product Characteristics
ColorWHITE, BLUEScoreno score
ShapeROUNDSize13mm
FlavorImprint CodeBP50
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-228-501 BOTTLE, PLASTIC in 1 BOX
150 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/29/2014
Labeler - EQUALINE (SuperValu) (006961411)

 
EQUALINE (SuperValu)

← See all Acetaminophen PM Extra Strength 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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