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Tension Headache Relief by CHAIN DRUG MARKETING ASSOCIATION INC

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 65mg
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-030

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.

Quality Choice 44-428

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

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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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

QC®
QUALITY
CHOICE

NDC 63868-030-10

Compare to the active ingredients in EXCEDRIN® TENSION HEADACHE*

Tension Headache Relief
Acetaminophen, 500 mg and Caffeine, 65 mg

Pain Reliever
Aspirin Free

Actual
Size

100 Coated 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, Inc., owner of the registered trademark
Excedrin® Tension Headache.

50844      REV0417A42812

SATISFACTION 100% QC GUARANTEED 

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com

Questions: 248-449-9300

Quality Plus 44-428



TENSION HEADACHE RELIEF 
acetaminophen, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-030
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSPOVIDONE 
D&C RED NO. 27 
FD&C BLUE NO. 2 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize17mm
FlavorImprint Code44;428
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-030-101 BOTTLE in 1 CARTON
1100 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/17/2007
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63868-030)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63868-030)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63868-030)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63868-030)

 
CHAIN DRUG MARKETING ASSOCIATION INC

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Medically reviewed on Aug 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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