NDC | 70242-102-06 |
Set ID | fef0c576-5fe2-42c5-9c4f-47dab6e940bb |
Category | HUMAN OTC DRUG LABEL |
Packager | Dannso Corp./d.b.a. Essential Products |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
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ACTIVE INGREDIENT
Active Ingredients:(in each 10 ml.) Purpose Acetaminophen 250 mg ........................................................
Analgesic
Dextromethorphan Hydrobromide 13.33 mg .......................
Cough Suppressant
Guaifenesin USP 200 mg......................................................
Expectorant
Phenylephrine HCl 5 mg.......................................................
Decongestant
- PURPOSE
- WARNINGS
-
DO NOT USE
- Adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- Child takes more than 5 doses in 24 hours
- Taken with other drugs containing Acetaminophen.
- Adult has 3 or more alcoholic drinks every day while using this product
- Do not give to children under 3 years of age or use for more than 10 days unless directed by a physician
- Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric conditions, or Parkinson's disease) or for 2 weeks after stopping MAOI drug.
- If you do not know if your prescription drug contains MAOI as your doctor or pharmacist before taking this product.
- If you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
- Avoid alcoholic beverage while taking this product.
- Do not use with any other drug containing Acetaminophen (prescription no nonprescription) If you are not sure whether a drug contains Acetaminophen, ask a doctor or pharmacist
Stop use and ask a doctor
- Nervousness, dizziness or sleeplessness occurs.
- Cough persists more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. A persistent cough may be signserious condition.
-
ASK DOCTOR
Ask doctor before use if you have
- Cough that occurs with too much phlegm(mucus)
- Cough that last or is a chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
- Heart disease, high blood pressure, thyroid disease, or difficulty in urination due enlargement of prostate gland.
- The user has Liver diseases
- The user us taking the blood thinning drug Warfarin
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- Inactive Ingredient
- Questions or Comments
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BRONCOMAR EXPECTORANT
acetaminofen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70242-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 13.33 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70242-102-06 1 in 1 CARTON 01/01/2015 1 177 mL in 1 BOTTLE; 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 10/01/2001 Labeler - Dannso Corp./d.b.a. Essential Products (059741071) Registrant - Dannso Corp./d.b.a. Essential Products (059741071) Establishment Name Address ID/FEI Business Operations All Pharma LLC 078572520 MANUFACTURE(70242-102)