NDC 58552-137

Giltuss Childrens MultiSymptom Cold and Flu

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Giltuss Childrens MultiSymptom Cold and Flu is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Giltuss Pharmaceutical Corp. The primary component is Chlorpheniramine Maleate; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide; Acetaminophen.

• Product ID: 58552-137_852c8cd6-2720-0fa8-e053-2991aa0ab179
• NDC: 58552-137
• Product Type: Human Otc Drug
• Proprietary Name: Giltuss Childrens MultiSymptom Cold and Flu
• Generic Name: Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-02
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Giltuss Pharmaceutical Corp
• Substance Name: CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
• Active Ingredient Strength: 2 mg/5mL; mg/5mL; mg/5mL; mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58552-137-04

1 BOTTLE in 1 CARTON (58552-137-04) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2018-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58552-137-04 [58552013704]

Giltuss Childrens MultiSymptom Cold and Flu SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-02

Drug Details

Active Ingredients

Ingredient	Strength
CHLORPHENIRAMINE MALEATE	2 mg/5mL

OpenFDA Data

• SPL SET ID: 852c8cd6-271f-0fa8-e053-2991aa0ab179
• Manufacturer:
  • Giltuss Pharmaceutical Corp
• UNII:
  • V1Q0O9OJ9Z
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 2121065

NDC Crossover Matching brand name "Giltuss Childrens MultiSymptom Cold and Flu" or generic name "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
58552-137	Giltuss Childrens MultiSymptom Cold and Flu	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
0280-1212	Alka-Seltzer Plus Maximum Strength Cold and Cough	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
0280-0023	Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
0280-1560	Alka-Seltzer Plus Severe Cold and Flu	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
48201-009	Calmadol Plus	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
56062-239	childrens cold and flu	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
63868-374	Childrens Multi-Symptom Cold Plus	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
0363-0034	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
11822-5047	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
15127-931	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
21130-034	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
41520-704	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
46122-310	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
55315-304	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
55910-043	Childrens Plus Multi Symptom Cold	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
51467-007	COLTALIN-DM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
55910-014	DG Health cold multi symptom	Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
58552-136	Giltuss MultiSymptom Cold and Flu	Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide, Phenylephrine hydrochloride
48201-001	Sanaflu Xtra	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
49873-114	Stona	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
49873-113	Stona-S	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride
36800-809	topcare childrens cold and flu	acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride