Label: BC- aspirin and caffeine powder
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NDC Code(s):
63029-992-02,
63029-992-06,
63029-992-18,
63029-992-24, view more63029-992-50
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 26, 2020
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Active ingredient
- Purpose
- Uses
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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.
- hives
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BC
aspirin and caffeine powderProduct 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:63029-992-02 2 in 1 PACKAGE; Type 0: Not a Combination Product 06/01/2012 2 NDC:63029-992-06 6 in 1 PACKAGE; Type 0: Not a Combination Product 06/01/2012 3 NDC:63029-992-18 18 in 1 BOX; Type 0: Not a Combination Product 06/01/2012 4 NDC:63029-992-24 24 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 NOT FINAL part343 06/01/2012 Labeler - Medtech Products Inc. (122715688)