Active ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

Pain reliever/Fever reducer

Uses

for the temporary relief of minor aches and pains due to:

headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe Liver damage may occur if you take

more than 4000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Do not use

with any other drug containing acetaminophen (prescription or non prescription). 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 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

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

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 the 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)
Adults and children 12 years and over:

take 2 tablets every 6 hours while symptoms last
do not take more than 6 tablets in 24 hours unless directed by a doctor
do not take more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information

Do not use if imprinted safety seal under cap is broken or missing.
Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

If you have any questions or comments, or to report an adverse event, please contact (888) 876-6898.

Principal Display Panel

fred's
See New Warnings Information and Directions

Extra Strength

Pain Reliever

Acetaminophen
Pain Reliever/Fever Reducer

fred's
LAB TESTED
Lab Tested for Quality
fred Tested for Satisfaction

100 Tablets, 500 mg Each

Compare To
Extra Strength
Tylenol®

ACETAMINOPHEN
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	55315-100
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND (round flat faced beveled edge)	Size	12mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	55315-100-01	100 TABLET In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	03/30/2012

Labeler - FREDS, INC (005866116)

Registrant - Gemini Pharmaceuticals, Inc. (055942270)

Establishment
Name	Address	ID/FEI	Operations
Gemini Pharmaceuticals, Inc.		055942270	manufacture

Revised: 04/2012FREDS, INC