BC SINUS CONGESTION AND PAIN- acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride 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 ingredients (in each powder)

Acetaminophen 650 mg
Chlorpheniramine maleate 4mg
Phenylephrine hydrochloride 10mg

Purposes

Pain reliever/Fever reducer
Antihistamine
Nasal decongestant

Uses

• temporarily relieves these allergy and cold symptoms:
  sinus congestion and pressure
  headache
  nasal congestion 
  runny nose
  sneezing
  minor anches and pains
  
• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg in 24 hours 
  
• with other drugs containing acetaminophen
  
• 3 or more alcoholic drinks every day while using this product

Allergy Alert: 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.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  
• if you are now taking a prescription monoamine oxidase inhibitor (MOAI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• liver disease
  
• high blood pressure
  
• diabetes
  
• thyroid disease
  
• glaucoma
  
• heart disease
  
• a breathing problem such as emphysema or chronic bronchitis
  
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking

• the blood thinning drug warfarin
  
• sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
  
• drowsiness may occur
  
• avoid alcoholic drinks
  
• excitability may occur, especially in children
  
• be careful when driving a motor vehicle or operating machinery
  
• alcohol, sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

• pain or nasal congestion gets worse or lasts more than 7 days
  
• fever gets worse or lasts more than 3 days
  
• you get nervous, dizzy, or sleepless
  
• redness or swelling is present
  
• new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children. 

Overdose warning: Taking more than the recommended dose can cause serious health problems. In the case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)
  
• adults and children 12 years of age and over: place 1 powder on tongue every 4-6 hours, while symptoms persist.
  
• do not take more than 6 powders in 24 hours unless directed by a doctor.
  
• children under 12 years of age: ask a doctor.

Other information

Store below 25°C (77°F)

Inactive ingredients

magnesium stearate, maltodextrin, silica

Questions?

1-866-255-5197 bcpowder.com

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

PRINCIPAL DISPLAY PANEL

BC™  Sinus Pain & Congestion

Acetaminophen       Pain Reliever / Fever Reducer
Chlorpheniramine       Maleate Antihistamine
Phenylephrine HCl       Nasal Decongestant

12 Powders

INGREDIENTS AND APPEARANCE

BC  SINUS CONGESTION AND PAIN
acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-221-04	4 in 1 CARTRIDGE; Type 0: Not a Combination Product	03/01/2016
2	NDC: 63029-221-12	12 in 1 CARTON; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2016

Labeler - Medtech Products Inc. (122715688)