TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet, film coated

Tension Headache Relief by

Drug Labeling and Warnings

Tension Headache Relief by is a Otc medication manufactured, distributed, or labeled by FRED'S, INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 500 mg
(formulated with 65 mg caffeine)

Purpose

Pain reliever

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches 

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 drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• blisters
• rash
• skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

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

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 for more than 10 days
• new symptoms occur
• fever gets worse or lasts for more than 3 days
• painful area is red or swollen

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed
  
• adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 6 caplets in 24 hours.
• children under 12 years: ask a doctor

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

corn starch, crospovidone, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide 

Questions or comments?

 1-800-426-9391

Principal Display Panel

Fred's
Pharmacy

NDC: 55315-428-08

Compare to the active ingredients in:
Excedrin® Tension Headache*

TENSION
HEADACHE RELIEF
Acetaminophen 500 mg, Caffeine 65 mg
Pain Reliever

Aspirin Free

24 CAPLETS

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

*This product is not manufactured or distributed by GSK group of companies, owner of the registered trademark Excedrin® Tension Headache.

50844   REV0417A42808

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

100% satisfaction
guaranteed

Questions or comments: 1-855-331-FRED (3733)

Freds Pharmacy 44-428

INGREDIENTS AND APPEARANCE

TENSION HEADACHE RELIEF 
acetaminophen, caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-428
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	44;428
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-428-08	1 in 1 CARTON	01/17/2007
1		24 in 1 BOTTLE; 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	01/17/2007

Labeler - FRED'S, INC. (005866116)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(55315-428)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(55315-428)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(55315-428)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(55315-428)