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Headache Relief by We Care Distributor Inc.

Dosage form: tablet
Ingredients: Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg
Labeler: We Care Distributor Inc.
NDC Code: 70005-004

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.

Headache Relief - Acetaminophen, Aspirin and Caffeine

Drug Facts

Active ingredients (in each tablet)Purposes
nonsteroidal anti-inflammatory drug
Acetaminophen 250 mgPain reliever
Aspirin 250 mg (NSAID)Pain reliever
Caffeine 65 mgPain reliever aid

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • a cold
    • arthritis
    • muscular aches
    • sinusitis
    • toothache
    • premenstrual & menstrual cramps

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • adult takes more than 8 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 tablets in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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 have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
  • 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
  • stomach bleeding warning applies to you
  • you have not been drinking fluids
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
  • you have lost a lot of fluids due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are taking

  • any other drug containing an NSAID (prescription or nonprescription)
  • a blood thinning (anticoagulant) or steroid drug
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor's care for any serious condition

Stop use and ask a doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • ringing in the ears or loss of hearing occurs
    • 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
    • any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 tablets every 6 hours; do not take more than 8 tablets 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)

  • read all product information before using. Keep this box for important information

Inactive ingredients

hypromellose, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, silicon dioxide, stearic acid, talc

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

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Compare to the Active Ingredients in
EXCERDRIN
  EXTRA STRENGTH

Acetaminophen, Asprin (NSAID) and Caffeine

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Caplets Each

HEADACHE RELIEF 
acetaminophen, aspirin, and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen250 mg
Aspirin (Aspirin) Aspirin250 mg
Caffeine (Caffeine) Caffeine65 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
SILICON DIOXIDE 
STARCH, PREGELATINIZED CORN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STEARIC ACID 
TITANIUM DIOXIDE 
TALC 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeET29
Contains    
Packaging
#Item CodePackage Description
1NDC:70005-004-2525 POUCH in 1 BOX
12 TABLET in 1 POUCH
2NDC:70005-004-5050 POUCH in 1 BOX
22 TABLET in 1 POUCH
3NDC:70005-004-022 POUCH in 1 POUCH
32 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/09/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIOperations
Elysium Pharmaceutical Ltd.915664486manufacture(70005-004)

 
We Care Distributor Inc.

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Medically reviewed on Feb 9, 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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