Label: BC DAYTIME MULTI-SYMPTOM- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powder
- NDC Code(s): 63029-215-04, 63029-215-12
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated May 10, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Uses
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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
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.
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.
- more than 4,000 mg in 24 hours
- Directions
- Other information
- Inactive ingredients
- Questions?
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BC DAYTIME MULTI-SYMPTOM
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride powderProduct 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)
