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Tension Headache Aspirin-Free by CVS Pharmacy

Medically reviewed on September 26, 2017.

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 65mg
Labeler: CVS Pharmacy
NDC Code: 59779-972

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.

CVS 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 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 of 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 occur
  • 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 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

♥︎CVS Health

Compare to the active ingredients in Excedrin® Tension Headache Express Gels™*

Rapid Release Gelcaps

NDC 59779-972-09

Aspirin-Free
Tension
Headache   
                      RAPID RELEASE
ACETAMINOPHEN
& CAFFEINE

Pain reliever, Pain reliever aid

20 GELCAPS

Actual Size

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

*This product is not manufactured or distributed by Novartis Consumer Health, Inc.,owner of the registered trademark Excedrin® Tension Headache Express Gels™.
50844       ORG061557209

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

V-11112

✓CVS®Quality
Money Back Guarantee

CVS 44-572

TENSION HEADACHE  ASPIRIN-FREE
acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-972
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 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED (red with white band in the middle) Scoreno score
ShapeOVALSize20mm
FlavorImprint CodeL;2
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-972-091 BOTTLE in 1 CARTON
120 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/09/2009
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-972)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-972)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(59779-972)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-972)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-972)

 
CVS Pharmacy

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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