Bc Daytime Multi-Symptom (Acetaminophen, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride) Powder [Medtech Products Inc.] -

BC DAYTIME MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER [MEDTECH PRODUCTS INC.]
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NDC	63029-215-04, 63029-215-12
Set ID	1f653f79-63b9-4c2b-8fe6-d7bb29d84636
Category	HUMAN OTC DRUG LABEL
Packager	Medtech Products Inc.
Generic Name
Product Class	alpha-1 Adrenergic Agonist
Product Number
Application Number	PART341

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	05/07/2018

Labeler - Medtech Products Inc. (122715688)

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Medic

BC DAYTIME MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER [MEDTECH PRODUCTS INC.]

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use

When using this product,

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

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