Kmart - pain relief pm solution

Drug facts

Active ingredients (in each15 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 drinksevery day whileusing 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 couldbe 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 cupdesigned 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 20-25C (68-77F). 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 Red no. 40, 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?

1-855-274-4122

Distributed by:
Kmart Corporation
Hoffman Estates, IL 60179
Shop kmart.com

Ingredients and appearance - Product information

Kmart - pain relief pm solution- Acetaminophen and diphenhydramine hcl

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 49738-999
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 15 mL
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 25 mgin 15 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Peppermint ( UNII: V95R5KMY2B)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Menthol, unspecified form ( UNII: L7T10EIP3A)
Sorbitol ( UNII: 506T60A25R)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Carboxymethylcellulose sodium, unspecified form ( UNII: K679OBS311)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color PURPLE Flavor PEPPERMINT

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49738-999-20 237mL in 1 BOTTLE 2015/08/17

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2015/08/17

Labeler - Kmart Corporation( 008965873)

Establishment

Name ID/FEI Business Operations
Kmart Corporation 008965873 MANUFACTURE( 49738-999)

Package label-principal display panel 8 fl oz (237 ml bottle)

NDC 49738-999-20
smart
sense®

COMPARE TO THE
ACTIVE INGREDIENTS
IN TYLENOL® PM
TABLET*

SEE WARNINGS INFORMATION

pain relief PM

Acetaminophen,
Diphenhydramine HCl
PAIN RELIEVER, NIGHTTIME SLEEP AID
COOL MINT FLAVOR

ALCOHOL
FREE
DO NOT USE IF PRINTED
SHRINKBAND IS
MISSING OR BROKEN.

8 FL OZ (237mL)