BC MAX- aspirin, acetaminophen, caffeine powder

BC MAX by

Drug Labeling and Warnings

BC MAX 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

BC™ 

MAX SRENGTH

ACETAMINOPHEN & ASPIRIN (NSAID) / CAFFEINE

PAIN RELIEVER / PAIN RELIEVER AID

16 PACKS

LEMONADE FLAVOR

DRUG FACTS

Attention: Contains acetaminophen. Read entire label before use.

Drug Facts                                                                

Active ingredients (in each powder):

Purposes

Aspirin (NSAID*) 500 mg…………………………………......Pain reliever

Acetaminophen 500mg…………………………………………Pain reliever

Caffeine 65 mg……………………………….…………………Pain reliever aid

*nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains due to:

• headache
  
• backache
  
• muscle aches
  
• toothache
  
• menstrual crams
  
• colds
  
• minor arthritis pain

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 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 (1-800-222-1222) right away.

Directions

• Do not take more than directed (see overdose warning)
  
• 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.

Other information

Store below 25°C (77°F)

Inactive ingredients  

flavor, guar gum, mannitol, microcrystalline cellulose, silicon dioxide, sucralose, xylitol

Questions?

1-866-255-5197 BCpowder.com

TAMPER EVIDENT: DO NOT USE IF PACK IS DAMAGED OR OPEN.

TO OPEN CHILD RESISTENT PACKAGE

1. SHAKE PACK so powder settles on bottom
   
2. Pinch and tear at either arrow or use scissors

PRINCIPAL DISPLAY PANEL

BC
MAX SRENGTH

ACETAMINOPHEN & ASPIRIN (NSAID) / CAFFEINE

PAIN RELIEVER / PAIN RELIEVER AID

16 PACKS

LEMONADE FLAVOR

INGREDIENTS AND APPEARANCE

BC MAX 
aspirin, acetaminophen, caffeine powder

Product 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: 63029-203-04	4 in 1 CARTON; Type 0: Not a Combination Product	10/01/2020
2	NDC: 63029-203-16	16 in 1 CARTON; Type 0: Not a Combination Product	03/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	03/15/2020

Labeler - Medtech Products Inc. (122715688)