BC Daytime Multi-Symptom: Package Insert and Label Information

BC DAYTIME MULTI-SYMPTOM- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride powder
Medtech Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

(in each powder)
Acetaminophen 650 mg
Dextromethorphan HBr 20mg
Phenylephrine hydrochloride 10mg

Purposes

Pain reliever/Fever reducer
Cough suppressantNasal 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

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 i ngredients

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 SuppressantPhenylephrine HCl – Nasal Decongestant

12 Powders

BC™ Daytime Multi-Symptom

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

12 Powders
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

BC™ Daytime Multi-Symptom

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

4 Powders

BC™ Daytime Multi-Symptom

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

4 Powders
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 20 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MALTODEXTRIN
SILICON DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-215-04 4 POWDER in 1 CARTON None
2 NDC:63029-215-12 12 POWDER in 1 CARTON None
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)

Revised: 05/2018 Medtech Products Inc.

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