NDC 70000-0525

Severe Cold and Flu

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Severe Cold and Flu is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Cardinal Health 110, Llc. Dba Leader. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 70000-0525_00a45c69-f194-4404-b2ae-03ff66c35f45
• NDC: 70000-0525
• Product Type: Human Otc Drug
• Proprietary Name: Severe Cold and Flu
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-10-25
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Cardinal Health 110, LLC. DBA Leader
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/1; mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 70000-0525-1

2 BLISTER PACK in 1 CARTON (70000-0525-1) > 12 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 2019-10-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70000-0525-1 [70000052501]

Severe Cold and Flu TABLET, FILM COATED

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-10-25

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/1

NDC Crossover Matching brand name "Severe Cold and Flu" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
0363-0603	Severe Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0363-0623	severe cold and flu	Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
68998-163	Severe Cold and Flu	Severe Cold and Flu
15127-184	Severe Cold and Flu	Severe Cold and Flu
37808-619	severe cold and flu	severe cold and flu
42507-603	Severe Cold and Flu	Severe Cold and Flu
49035-945	Severe Cold and Flu	Severe Cold and Flu
56062-319	severe cold and flu	severe cold and flu
0363-0763	Severe Cold and Flu	Severe Cold and Flu
0363-1597	Severe Cold and Flu	Severe Cold and Flu
62011-0241	Severe Cold and Flu	Severe Cold and Flu
63868-003	Severe Cold and Flu	Severe Cold and Flu
0363-1940	severe cold and flu	severe cold and flu
69842-972	Severe Cold and Flu	Severe Cold and Flu
63940-342	Severe Cold and Flu	Severe Cold and Flu
70000-0525	Severe Cold and Flu	Severe Cold and Flu
0113-7603	Basic Care Daytime Cold and Flu Severe	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-7303	basic care mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0640	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0299	good sense cold and flu severe	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0234	good sense cold head congestion	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0381	Good Sense Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-1913	good sense mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0579	good sense severe cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0548	Good Sense Severe Daytime	acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0603	Good Sense Severe Daytime Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-9007	Good Sense Severe Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0363-0616	Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0538	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0372	Mucus Relief Plus	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0410	Mucus Relief Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0503	Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0524	Sinus Relief	Acetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
0067-8145	Theraflu ExpressMax Severe Cold and Flu Caplets	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0067-8132	Theraflu ExpressMax Severe Cold and Flu Syrup	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0051	Wal Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl