Fred's Extra Strength Pain Reliever Caplets

Drug Labeling and Warnings

Drug Details [pdf]

ACETAMINOPHEN- acetaminophen tablet 
FREDS, INC

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.

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Fred's Extra Strength Pain Reliever Caplets

Active ingredient (in each caplet)

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 caplets (3,000 mg) in 24 hours. 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
  

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 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 caplets every 6 hours while symptoms last
• do not take more than 6 caplets 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

• Store at room temperature
  

Inactive ingredients

Hypromellose,Polyethylene Glycol, 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 Caplets, 500 mg Each

Compare To Extra Strength Tylenol®

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-101
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
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Capsule shaped tablet)	Size	18mm
Flavor		Imprint Code	GPI;A5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-101-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/10/2012	05/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/10/2012	05/31/2019

Labeler - FREDS, INC (005866116)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc.		055942270	manufacture(55315-101)

Revised: 11/2017

Document Id: 5df43cdd-928b-2868-e053-2991aa0ac410

34390-5

Set id: 0b6ce6db-e8a6-439e-add0-a7e3c488144f

Version: 2

Effective Time: 20171114

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