BC Arthritis: Package Insert and Label Information

BC ARTHRITIS- aspirin and caffeine powder
Medtech Products Inc.

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 Facts

Active ingredient

(in each powder)

Aspirin (NSAID*) 1000 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 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

  • each powder contains: potassium 6 5 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
Arthritis FORMULA
FOR TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN50 POWDERS

BC®
ASPIRIN (NSAID) – PAIN RELIEVER ● FEVER REDUCER
CAFFEINE – PAIN RELIEVER AID
FAST PAIN RELIEF
Arthritis FORMULA
FOR TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN
50 POWDERS
(click image for full-size original)
BC ARTHRITIS aspirin and caffeine powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-990
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
SODIUM BENZOATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-990-02 24 POWDER in 1 BOX None
2 NDC:63029-990-06 6 POWDER in 1 PACKAGE None
3 NDC:63029-990-50 50 POWDER in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 06/01/2012
Labeler — Medtech Products Inc. (122715688)

Revised: 06/2020 Medtech Products Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.