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Pain Reliever PM Extra Strength

Medically reviewed on Oct 11, 2017

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Salado Sales, Inc.
NDC Code: 57243-235

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.

CVP 44-235

Active ingredients (in each caplet)

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.

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 product containing diphenhydramine, even one used on skin

  • in children under 12 years of age

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis

  • liver disease

  • glaucoma

  • difficulty in urination due to enlargement of the 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

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
  • adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
  • children under 12 years: do not use

Other information
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

CVP®
HEALTH

COMPARE TO EXTRA STRENGTH TYLENOL® PM ACTIVE INGREDIENTS*

PAIN RELIEVER COMBINED WITH AN INGREDIENT TO HELP YOU FALL ASLEEP SAFELY!

EXTRA STRENGTH
PAIN
RELIEVER PM
ACETAMINOPHEN

DIPHENHYDRAMINE HCl

PAIN RELIEVER/
NIGHTTIME SLEEP AID

NON-ASPIRIN

50
EASY TO SWALLOW
CAPLETS

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® PM.

50844    REV0417P23515

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

Distributed by Consumer Value Products, Inc.
P.O. Box 6115. Temple, Texas 76502
CVPproducts.com

CVP 44-235

PAIN RELIEVER PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-235
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 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;235
Contains    
Packaging
#Item CodePackage Description
1NDC:57243-235-151 BOTTLE, PLASTIC in 1 CARTON
150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/15/1994
Labeler - Salado Sales, Inc. (009830555)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(57243-235)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837MANUFACTURE(57243-235), PACK(57243-235)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(57243-235)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(57243-235)

 
Salado Sales, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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