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Tension Headache by Meijer Distribution Inc

Medically reviewed on May 23, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 65mg
Labeler: Meijer Distribution Inc
NDC Code: 41250-572

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.

Meijer 44-572

Active ingredients (in each gelcap)

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. The maximum daily dose of this product is 6 gelcaps (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

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

  • skin reddening
  • blisters
  • rash

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 heart beat.

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
  • new symptoms occur
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts 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 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 gelcaps every 6 hours. Do not take more than 6 gelcaps in 24 hours.
  • children under 12 years: ask a doctor

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

Inactive ingredients

colloidal silicon dioxide, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

NDC 41250-572-12

meijer™

Rapid Release
TensionHeadache
Acetaminophen •
Caffeine

Pain Reliever / Pain Reliever Aid

Contains No Aspirin

100 Gelcaps

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

50844    REV0615A57212

DIST. BY MEIJER
DISTRIBUTION INC.
GRAND RAPIDS, MI 49544
www.meijer.com

Meijer 44-572

TENSION HEADACHE 
acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-572
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN, UNSPECIFIED 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE, UNSPECIFIED 
STARCH, CORN 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;2
Contains    
Packaging
#Item CodePackage Description
1NDC:41250-572-151 BOTTLE in 1 CARTON
150 TABLET in 1 BOTTLE
2NDC:41250-572-121 BOTTLE in 1 CARTON
2100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/09/2009
Labeler - Meijer Distribution Inc (006959555)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(41250-572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(41250-572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(41250-572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(41250-572)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(41250-572)

 
Meijer Distribution Inc

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Further information

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

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