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Pain Relief PM by Family Dollar, Inc.

Medically reviewed on July 3, 2017

Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL, DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 15mL
Labeler: Family Dollar, Inc.
NDC Code: 55319-998

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 15 mL)

Acetaminophen USP 500 mg

Diphenhydramine HCl USP 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 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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • for 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 or any other sleep aid

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.
  • Pain gets worse or lasts more than 10 days
  • Fever gets worse or lasts more than 3 days
  • Redness or swelling is present
  • New symptoms occur

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. (1-800-222-1222) 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)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over
  • take 30 mL at bedtime
  • do not take more than 30 mL in 24 hours
children under 12 years
do not use

Other information
  • each 15 mL contains: sodium 9 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • don't use if shrink band is missing or broken
  • see back label for lot number and expiration date

Inactive ingredients

anhydrous citric acid, FD&C Blue no.1, FD&C Green no. 3, flavors, high fructose corn syrup, menthol, non-crystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, and sucralose

Questions or comments?

1-866-377-6420

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed By:
Family Dollar Services, LLC.
10401 Monroe Rd.
Matthews, NC 28105 USA
Made in the U.S.A
Not 100% Satisfied? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.
Visit FamilyDollar.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL8 FL OZ (237 mL Bottle)

NDC 55319-998-20

See Warnings Information


FAMILY

          wellness TM

Pain Reliever, Nighttime Sleep Aid


Pain Relief PM

Acetaminophen 500 mg,
Diphenhydramine HCl 25 mg


8 FL OZ                     BERRY

(237 mL)           ALCOHOL FREE

DO NOT USE IF PRINTED SHRINKBAND IS MISSING OR BROKEN.

PAIN RELIEF PM 
acetaminophen, diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-998
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg  in 15 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C GREEN NO. 3 
BERRY 
PEPPERMINT 
HIGH FRUCTOSE CORN SYRUP 
MENTHOL 
SORBITOL 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SUCRALOSE 
Product Characteristics
ColorBLUE (blue to bluish green) Score    
ShapeSize
FlavorBERRY, PEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-998-201 BOTTLE in 1 CARTON
1237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/23/2015
Labeler - Family Dollar, Inc. (024472631)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(55319-998)

 
Family Dollar, Inc.

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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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