BC- aspirin and caffeine powder

BC by

Drug Labeling and Warnings

BC by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

(in each powder)

Aspirin (NSAID*) 845 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Active ingredient

(in each powder)

Caffeine 65 mg

Purpose

Pain reliever aid

Uses

• temporary relieves minor aches and pains due to:
  ° headaches
  ° 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 non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  
• have 3 or more alcoholic drinks every day while using this product
  
• take more or for 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 warnings 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
  ° vomit blood
  ° have bloody or black stools
  ° have 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 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

• 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

BC®
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
50 POWDERS

INGREDIENTS AND APPEARANCE

BC 
aspirin and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-992
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	845 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
FUMARIC ACID (UNII: 88XHZ13131)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-992-24	24 in 1 BOX; Type 0: Not a Combination Product	06/01/2012
2	NDC: 63029-992-02	2 in 1 PACKAGE; Type 0: Not a Combination Product	06/01/2012
3	NDC: 63029-992-06	6 in 1 PACKAGE; Type 0: Not a Combination Product	06/01/2012
4	NDC: 63029-992-18	18 in 1 BOX; Type 0: Not a Combination Product	06/01/2012
5	NDC: 63029-992-50	50 in 1 BOX; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	06/01/2012

Labeler - Medtech Products Inc. (122715688)