Tension Headache Relief: Package Insert and Label Information

TENSION HEADACHE RELIEF- acetaminophen and caffeine tablet, film coated
Target Corporation

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.

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 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.

I n 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?

Call 1-800-910-6874

Principal display panel

NDC 11673-428-12

Compare to active ingredients in
Excedrin® Tension Headache*

tension headache relief acetaminophen , 500 mg and caffeine, 65 mg

pain reliever
aspirin free

up & up

100 COATED CAPLETS

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 GSK
group of companies, owner of the registered trademark
Excedrin® Tension Headache.

50844 REV0417F42812

094 01 0552 R02 ID225402
Distributed by Target Corporation
Minneapolis, MN 55403
© 2018 Target Brands, Inc.
Shop Target.com

Target 44-428
(click image for full-size original)

Target 44-428

TENSION HEADACHE RELIEF
acetaminophen, caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-428
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 27 ALUMINUM LAKE
TALC
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
STEARIC ACID
TITANIUM DIOXIDE
CROSPOVIDONE
FD&C BLUE NO. 2–ALUMINUM LAKE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color RED Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 44;428
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11673-428-12 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (11673-428-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 01/17/2007
Labeler — Target Corporation (006961700)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (11673-428)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE (11673-428)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (11673-428)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 PACK (11673-428)

Revised: 05/2020 Target Corporation

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