Your browser does not support JavaScript! PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [H E B]
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PAIN RELIEVER PM EXTRA STRENGTH (acetaminophen, diphenhydramine hcl) capsule
[H E B]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active ingredients (in each gelcap)

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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product 

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • avoid alcoholic beverages
  • drowsiness will occur
  • 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 a 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: 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. 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage. 

Other information

  • store at 25ºC (77ºF); ecursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinied starch, propylene gllycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Compare to Extra Strength Tylenol® PM Rapid Release Gels active ingredients*

NDC 37808-556-09

H-E-B®
PAIN RELIEF PM
Extra Strength    •    Rapid Release
Acetaminophen, Diphenhydramine HCl
Pain Reliever/Nighttime Sleep-Aid
Non-Habit Forming

20 Gelcaps

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM Rapid Release Gels.
50844    ORG071255609    1212

MADE WITH PRIDE AND CARE FOR H-E-B, SAN ANTONIO, TX 78204

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

HEB 44-556

HEB 44-556

PAIN RELIEVER PM EXTRA STRENGTH 
acetaminophen, diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37808-556
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
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 3 
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code L;6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-556-091 in 1 CARTON
120 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34112/17/2007
Labeler - H E B (007924756)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37808-556)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37808-556)

Revised: 2/2013
 
H E B

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