Label: BRONCOLIN COLD AND FLU RELIEF- acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
- NDC Code(s): 66513-468-12
- Packager: Broncolin S.A de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated July 6, 2016
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- Active ingredients (in each softgel)
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- 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
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 (MAOI) (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
- heart disease
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- nervousness, dizziness, or sleeplessness occur
- fever gets worse or lasts more than 3 days
- 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 liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- adults and children 12 years and over: take 2 softgels with water every 4 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- Other information
butylated hydroxyanisole*, butylated hydroxytoluene*, carminic acid*, edible white ink, D&C yellow #10*, FD&C red #40, FD&C yellow#6, gelatin, glycerin, polyethylene glycol*, povidone, propylene glycol, purified water, sodium metabisulfite*, sorbitan*, sorbitol
*contains one or more of these ingredients
- Questions or comments?
Principal Display Panel
Cold and Flu Relief
Acetaminophen/Dextromethorphan HBr/Phenylephrrine HCl
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Broncolin S.A de C.V
Midway Importing, Inc.
1807 Brittmoore Road Houston,
- Package Label
INGREDIENTS AND APPEARANCE
BRONCOLIN COLD AND FLU RELIEF
acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66513-468 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) CARMINIC ACID (UNII: CID8Z8N95N) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) SODIUM METABISULFITE (UNII: 4VON5FNS3C) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P19;95A;512;P119 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66513-468-12 12 in 1 CARTON 04/30/2016 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/30/2016 Labeler - Broncolin S.A de C.V. (814400404)