PAIN RELIEF ES- acetaminophen tablet

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by American Sales Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

 Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

temporary relief of minor aches and pains associated with   ■ common cold  ■ headache  ■ toothache  ■ muscular aches  ■ backache           ■ arthritis  ■ menstrual cramps  ■ and reduction of fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take   ■ more than 4000mg 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

Do not use

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

Ask a doctor before use if you have

liver disease. 

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

■ symptoms do not improve   ■ pain gets worse or lasts more than 10 days   ■ fever gets worse or lasts more than 3 days   ■ new symptoms occur   ■ redness or swelling is present   ■ a rare sensitivity reaction occurs 

If pregnant or breast-feeding,

ask a professional before use.

Keep out of reach of children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Directions

■ do not use more than directed (see overdose warning)
■  adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours.
■  children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
■  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 (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.

Other information

 ■ store at room temperature  ■ do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide. 

Principal Display Panel

CAREONE®

Compare to the Active ingredient in Tylenol®.

EXTRA STRENGTH ACETAMINOPHEN

500 mg
Pain Reliever/Fever Reducer

24 CAPLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®.

DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785
1-877-846-9949©2016 S&S Brands, LLC
Quality Guaranteed Or Your Money Back

LB0654
R0216

LB0654_R0216

 

LB0653_R0216

INGREDIENTS AND APPEARANCE

PAIN RELIEF  ES
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	POVIDONES (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	AZ012
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-012-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	06/10/2014

Labeler - American Sales Company (809183973)