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STANBACK

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Aspirin (NSAID*) 845 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

Pain reliever aid

  • •temporarily relieves minor aches and pains due to:
    • ∘headache
    • ∘muscular aches
    • ∘minor arthritis pain
    • ∘colds
  • •temporarily reduces fever

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
  • •shock
  • •asthma (wheezing)

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

Do Not Use

If you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

  • •stomach bleeding warning applies to you
  • •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

Ask a doctor or pharmacist before use if you are

Taking a prescription drug for diabetes, gout, or arthritis

When using this product

Limit the use of caffeine-containing drugs, foods, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

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:
    • ofeel faint
    • ovomit blood
    • ohave bloody or black stools
    • ohave stomach pain that does not get better
  • •pain gets worse or lasts more than 10 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •any new symptoms appear
  • •ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition.

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 right away.

Directions

  • •adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may stir powder into a glass of water or other liquid.
  • •do not take more than 4 powders in 24 hours unless directed by a doctor.
  • •children under 12 years of age: ask a doctor.

STANBACK Other information

  • each powder contains: potassium 55 mg
  • •store below 25oC (77oF)

Inactive ingredients

docusate sodium, fumaric acid, lactose monohydrate, potassium chloride

Questions or comments?

1-866-255-5197 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0499-50

STANBACK®

SNAP BACK WITH STANBACK®

Headache Powders

ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER

CAFFEINE - PAIN RELIEVER AID

RELIEVES PAIN FAST

FOR TEMPORARY RELIEF OF MINOR ACHES & PAIN DUE TO

HEADACHES - BODY ACHES

ARTHRITIS - COLDS & FEVER

50 POWDERS

TAMPER EVIDENT FEATURE: DO NOT USE IF SAFETY OVERWRAP OR "S" TEAR-TAPE IS MISSING OR TORN.

Distributed by: GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2011 GlaxoSmithKline

STANBACK AND SNAP BACK WITH STANBACK are registered trademarks of the GlaxoSmithKline group of companies.

30643XD

STANBACK

aspirin and caffeine POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0135-0499
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 845 mg
CAFFEINE 65 mg

Inactive Ingredients

Ingredient Name Strength
DOCUSATE SODIUM
FUMARIC ACID
lactose monohydrate
potassium chloride

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0135-0499-06 6 in 1 PACKAGE
2 NDC:0135-0499-24 24 in 1 CARTON
3 NDC:0135-0499-50 50 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2010-06-08


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Be sure to consult your doctor before taking any medication!
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