NDC 65131-097 – Broncochem Cold And Flu Tea
Acetaminophen 500 mg/13g; Chlorpheniramine Maleate 4 mg/13g · Granule, For Solution · Oral
Product NDC65131-097
Product details
- Brand name
- Broncochem Cold And Flu Tea
- Generic name
- Acetaminophen-phenylephrine Hydrochloride-chlorpheniramine Maleate
- Labeler
- LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Dosage form
- Granule, For Solution
- Route
- Oral
- Marketing category
- OTC MONOGRAPH DRUG · M
- Marketed since
- September 1, 2013
- Listing expires
- December 31, 2026
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Active ingredients
- Acetaminophen 500 mg/13g
- Chlorpheniramine Maleate 4 mg/13g
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 65131-097-12 | 25 PACKAGE in 1 BOX (65131-097-12) / 13 g in 1 PACKAGE (65131-097-52) | Sep 28, 2017 |
| 65131-097-53 | 6 PACKAGE in 1 BOX (65131-097-53) / 13 g in 1 PACKAGE (65131-097-52) | Sep 28, 2017 |
Recalls mentioning this NDC
- D-0387-2024 Mar 20, 2024 · Class II
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Other Broncochem products
- 65131-418 Chlorpheniramine Maleate 2 mg/10mL; Dextromethorphan Hydrobromide 10… · Syrup · LABORATORIO MAGANCEHM INTERNATIONAL SRL
- 65131-011 Acetaminophen 325 mg/10mL; Dextromethorphan Hydrobromide 20 mg/10mL;… · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-035 Dextromethorphan Hydrobromide 15 mg/5mL; Pyrilamine Maleate 6 mg/5mL · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-054 Acetaminophen 325 mg/10mL; Phenylephrine Hydrochloride 5 mg/10mL;… · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-091 Dextromethorphan Hydrobromide 30 mg/10mL; Guaifenesin 200 mg/10mL · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-098 Chlorpheniramine Maleate 4 mg/10mL; Phenylephrine Hydrochloride 10… · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-100 Dextromethorphan Hydrobromide 20 mg/10mL; Guaifenesin 400 mg/10mL · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-101 Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 20 mg/1;… · Tablet, Coated · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-109 Acetaminophen 325 mg/10mL; Phenylephrine Hydrochloride 10 mg/10mL;… · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-110 Dextromethorphan Hydrobromide 30 mg/5mL; Pyrilamine Maleate 50 mg/5mL · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-111 Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 30 mg/1;… · Tablet, Coated · LABORATORIO MAGNACHEM INTERNATIONAL SRL
- 65131-116 Acetaminophen 250 mg/10mL; Chlorpheniramine Maleate 4 mg/10mL;… · Syrup · LABORATORIO MAGNACHEM INTERNATIONAL SRL