Label: BC MAX- aspirin, acetaminophen, caffeine powder
- NDC Code(s): 63029-203-04, 63029-203-16
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 30, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each powder):
- Purposes
- 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 severe allergic reaction which may include:
• hives • facial swelling • shock • asthma (wheezing).
Acetaminophen may cause severe skin reactions. Symptoms may include
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.
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 a longer time than directed.
Caffeine warning:
This product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
Do not use
- if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
Ask a doctor before use if
- you have liver disease
- 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
- the blood thinning drug warfarin
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 stool
• have stomach pain that does not get better
• 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 you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
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Directions
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Do not take more than directed (see overdose warning)
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Adults and children 12 years 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: ask a doctor.
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Do not take more than directed (see overdose warning)
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BC MAX
aspirin, acetaminophen, caffeine powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-203 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength GUAR GUM (UNII: E89I1637KE) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color white Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-203-16 16 in 1 CARTON; Type 0: Not a Combination Product 03/15/2020 2 NDC:63029-203-04 4 in 1 CARTON; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/15/2020 Labeler - Medtech Products Inc. (122715688)
