NDC | 65131-054-18 |
Set ID | 523561fb-f6a7-4cde-9be2-bba02e60e208 |
Category | HUMAN OTC DRUG LABEL |
Packager | LABORATORIO MAGNACHEM INTERNATIONAL SRL |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
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Warnings
Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take:
More than 4 doses in 24 hour, wich is the maximum daily amount for this product.
With other drugs containing acetaminophen.
Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly.
allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include:
Sking reddening, blisters, rash. If sking reactions occurs, stop use and seek medical attention.
- Uses
- Active Ingredients
- Ask a doctor before use if your kid have
- Stop use and ask a doctor if
- Keep out of the reach of children
- Overdose warning
- Directions
- Other information
- Inactive ingredients
- Quiestions?
- Purose
- Package principal display panel
- Package Label Principal Display Panel
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BRONCOCHEM KIDS COLD AND FLU
acetaminophen-phenylephrine hcl-guaifenesin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65131-054 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.5 mL in 10 mL GLYCERIN (UNII: PDC6A3C0OX) 2.5 mL in 10 mL SORBITOL (UNII: 506T60A25R) 2 mL in 10 mL SUCRALOSE (UNII: 96K6UQ3ZD4) 15 mg in 10 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 20 mg in 10 mL DISODIUM HEDTA (UNII: KME849MC7A) 0.9 mg in 10 mL POVIDONE K90 (UNII: RDH86HJV5Z) 100 mg in 10 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) 40 mg in 10 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 6.25 mg in 10 mL HONEY (UNII: Y9H1V576FH) 100 mg in 10 mL PROPYL GALLATE (UNII: 8D4SNN7V92) 1 mg in 10 mL FD&C RED NO. 40 (UNII: WZB9127XOA) 0.16 mg in 10 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 4 mg in 10 mL METHYLPARABEN (UNII: A2I8C7HI9T) 10 mg in 10 mL PROPYLPARABEN (UNII: Z8IX2SC1OH) 1.5 mg in 10 mL RASPBERRY (UNII: 4N14V5R27W) 0.0048 mL in 10 mL WATER (UNII: 059QF0KO0R) 10 mL in 10 mL Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65131-054-18 1 in 1 BOX 05/01/2017 1 120 mL in 1 BOTTLE, PLASTIC; 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 05/01/2017 Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)