PAIN RELIEVER REGULAR STRENGTH- acetaminophen tablet

Pain Reliever by

Drug Labeling and Warnings

Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/ fever reducer

Uses

• temporarily relieves minor aches and pains due to
  • headache
  • the common cold
  • backache
  • minor pain of artritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

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 Contorl 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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
• children 6-11 years:
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
• children under 6 years:
  • ask a doctor

Other information

• store between 20-25ºC (68-77ºF)

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to the active ingredient of Tylenol® Regular Strength**

Regular Strength

Pain Reliever

Acetaminophen 325 mg

Pain Reliever/ Fever Reducer

For ages 6 years and over

Tablets

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Regular Strtength.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Product Label

DOLLAR GENERAL Regular Strength Pain Relief

INGREDIENTS AND APPEARANCE

PAIN RELIEVER  REGULAR STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-691
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL340
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-691-10	1 in 1 BOX	04/30/2018
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/30/2018

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)