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Name:Bc
Manufacturer:Glaxosmithkline Consumer Healthcare Lp
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BC - aspirin and caffeine powder 
BC ARTHRITIS - aspirin and caffeine powder 
GlaxoSmithKline Consumer Healthcare LP

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.

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Drug Facts

Active ingredient (in each powder)

Arthritis Formula

Aspirin (NSAID*) 1000 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Fast Pain Relief

Aspirin (NSAID*) 845 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Pain reliever aid

Uses

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

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
  • 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 heart beat. 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:
    • feel faint
    • have stomach pain that does not get better
    • vomit blood
    • have bloody or black stools
  • 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.

Other information

 

Arthritis Formula

  • each powder contains: potassium 65 mg
  • store below 25oC (77oF)

 

Fast Pain Relief

  • 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

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

Distributed by: GlaxoSmithKline Consumer Healthcare, L.P.

Memphis, TN 38113

www.bcpowder.com

Principal Display Panel

BC®

Same Fast Relief!

New Formula

ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER

CAFFEINE - PAIN RELIEVER AID

FAST PAIN RELIEF

Arthritis FORMULA

FOR TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN

See new warnings information.

50 POWDERS

©2009 GlaxoSmithKline

BC Arthritis Powder

Principal Display Panel

BC®

Same Fast Relief!

New Formula

ASPIRIN (NSAID) - PAIN RELIEVER - FEVER REDUCER

CAFFEINE - PAIN RELIEVER AID

FAST PAIN RELIEF

FOR PAIN DUE TO HEADACHES

TEMPORARY RELIEF OF MINOR BODY ACHES & FEVER

See new warnings information.

50 POWDERS

©2010 GlaxoSmithKline

BC Headache Powder


BC 
aspirin and caffeine powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0500
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 845 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM  
FUMARIC ACID  
LACTOSE MONOHYDRATE  
POTASSIUM CHLORIDE  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0500-06 6 POWDER ( PACKET) in 1 PACKAGE None
2 NDC:0135-0500-24 24 POWDER ( PACKET) in 1 CARTON None
3 NDC:0135-0500-50 50 POWDER ( PACKET) in 1 CARTON None
4 NDC:0135-0500-02 2 POWDER ( PACKET) in 1 PACKAGE None
5 NDC:0135-0500-18 18 POWDER ( PACKET) in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/08/2010

BC  ARTHRITIS
aspirin and caffeine powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0501
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 1000 mg
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM  
FUMARIC ACID  
LACTOSE MONOHYDRATE  
POTASSIUM CHLORIDE  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0501-06 6 POWDER ( PACKET) in 1 PACKAGE None
2 NDC:0135-0501-24 24 POWDER ( PACKET) in 1 CARTON None
3 NDC:0135-0501-50 50 POWDER ( PACKET) in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/08/2010

Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625)

Revised: 06/2010 GlaxoSmithKline Consumer Healthcare LP



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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