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:
  nasal and sinus congestion
  minor aches and pains
  itchy, watery eyes
  itching of the nose and throat
  runny nose
  headache
  sneezing
  
• temporarily reduces fever

Warnings

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

• more than 5 powders in 24 hours, which is the maximum daily amount
  
• 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

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 5 powders in 24 hours unless directed by a doctor.
  
• children under 12 years of age: ask a doctor.

Other information

• do not store above 25ᵒC (77ᵒF)

Inactive ingredients

corn starch
crospovidone
mannitol
povidone k30
silicified microcrystalline cellulose 
stearic acid

Questions?

1-866-255-5197

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

PRINCIPAL DISPLAY PANEL

BC™  Sinus Congestion & Pain

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

12 Powders

PRINCIPAL DISPLAY PANEL

BC™  Sinus Congestion & Pain

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

4 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: 63029-216
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
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE K30 (UNII: U725QWY32X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-216-04	4 in 1 CARTON; Type 0: Not a Combination Product	03/01/2016	06/30/2020
2	NDC: 63029-216-12	12 in 1 CARTON; Type 0: Not a Combination Product	03/01/2016	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2016	06/30/2020

Labeler - Medtech Products Inc. (122715688)