BC DAYTIME MULTI-SYMPTOM- acetaminophen, dextromethorphan hydrobromide, and 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 
Dextromethorphan HBr 20mg
Phenylephrine hydrochloride 10mg

Purposes

Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant

Uses

• temporarily relieves common cold & flu symptoms:
  nasal congestion
  cough due to minor throat and bronchial irritation
  fever
  minor aches and pains
  headache
  sore throat
  sinus congestion and pressure

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

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied by or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

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
  
• heart disease
  
• cough that occurs with too much phlegm (mucus)
  
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use

if you are taking the blood thinning drug warfarin

When using this product,

do not use more than directed

Stop use and ask a doctor if

• pain ,nasal congestion or cough 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
  
• cough comes back or occurs with rash or headache that lasts.

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 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 above 25ᵒC (77ᵒF)

Inactive ingredients

magnesium stearate, maltodextrin, silica

Questions?

1-866-255-5197 bcpowder.com

©2018 Distributed by Medtech Products Inc.
Tarrytown, New York 10591
A Prestige Brands Company
Made in USA

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

PRINCIPAL DISPLAY PANEL

BC™ Daytime Multi-Symptom

Acetaminophen – Pain Reliever / Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant

12 Powders

PRINCIPAL DISPLAY PANEL

BC™ Daytime Multi-Symptom

Acetaminophen – Pain Reliever / Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Phenylephrine HCl – Nasal Decongestant

4 Powders

INGREDIENTS AND APPEARANCE

BC  DAYTIME MULTI-SYMPTOM
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-215
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 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: 63029-215-04	4 in 1 CARTON; Type 0: Not a Combination Product	05/07/2018
2	NDC: 63029-215-12	12 in 1 CARTON; Type 0: Not a Combination Product	05/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	05/07/2018

Labeler - Medtech Products Inc. (122715688)