FDA.reportPublic FDA data

BC

Manufacturer
Medtech Products Inc.
Effective date
2018-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:48:34

Label at a glance#

ProductBC Sinus Congestion and Pain
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure11 sections

Indications and 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

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts                              

Active ingredients (in each powder)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg
Chlorpheniramine maleate 4mg
Phenylephrine hydrochloride 10mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer
Antihistamine
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • the blood thinning drug warfarin
  • sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • do not store above 25ᵒC (77ᵒF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch
crospovidone
mannitol
povidone k30
silicified microcrystalline cellulose 
stearic acid

Questions?

OTC - QUESTIONS SECTION

1-866-255-5197

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BC™  Sinus Congestion & Pain

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

12 Powders

BC™ Sinus Congestion & Pain Acetaminophen – Pain Reliever / Fever Reducer Chlorpheniramine Maleate – Antihistamine Phenylephrine HCl – Nasal Decongestant 12 PowdersBC™ Sinus Congestion & Pain Acetaminophen – Pain Reliever / Fever Reducer Chlorpheniramine Maleate – Antihistamine Phenylephrine HCl – Nasal Decongestant 12 Powders

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BC™  Sinus Congestion & Pain

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

4 Powders

BC™ Sinus Congestion & Pain Acetaminophen – Pain Reliever / Fever Reducer Chlorpheniramine Maleate – Antihistamine Phenylephrine HCl – Nasal Decongestant 4 PowdersBC™ Sinus Congestion & Pain Acetaminophen – Pain Reliever / Fever Reducer Chlorpheniramine Maleate – Antihistamine Phenylephrine HCl – Nasal Decongestant 4 Powders

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-216-04EA - Each63029-2161e69d2fd-e9d3-4657-90a1-3bc8bd5b2f3b12022-06-06
63029-216-12EA - Each63029-2166526d641-9612-4e67-992c-e03ef12f346512022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-21663029-216-04, 63029-216-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
MANNITOL3OWL53L36AIACT
POVIDONE K30U725QWY32XIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
32fb5faf-06c7-41d8-94bc-91566354612f2cdf53ea-ea99-49c4-935a-c103b52df83d2018-10-25WarningsExact identifier
spl id: 32fb5faf-06c7-41d8-94bc-91566354612f
spl set id: 2cdf53ea-ea99-49c4-935a-c103b52df83d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.