BC Sinus Congestion and Pain: Package Insert and Label Information

BC SINUS CONGESTION AND PAIN- acetaminophen, chlorpheniramine maleate 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 (i n each powder)

Acetaminophen 650 mg
Chlorpheniramine maleate 4mg
Phenylephrine hydrochloride 10mg

Purposes

Pain reliever/Fever reducer
AntihistamineNasal 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 i ngredients

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 – AntihistaminePhenylephrine HCl – Nasal Decongestant

12 Powders

BC™  Sinus Congestion & Pain

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

12 Powders
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

BC™Sinus Congestion & Pain

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

4 Powders

BC™  Sinus Congestion & Pain

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

4 Powders
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 4 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE
MANNITOL
POVIDONE K30
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-216-04 4 POWDER in 1 CARTON None
2 NDC:63029-216-12 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 03/01/2016 06/30/2020
Labeler — Medtech Products Inc. (122715688)

Revised: 10/2018 Medtech Products Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.