NDC 67060-106

COLD TABS II

Acetaminophen, Guaifenesin And Phenylephrine Hcl

COLD TABS II is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Advanced First Aid, Inc.. The primary component is Acetaminophen; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 67060-106_0636cfda-4705-4772-9eb8-d831a6d3046d
• NDC: 67060-106
• Product Type: Human Otc Drug
• Proprietary Name: COLD TABS II
• Generic Name: Acetaminophen, Guaifenesin And Phenylephrine Hcl
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2015-04-10
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: ADVANCED FIRST AID, INC.
• Substance Name: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 1/1; 1/1; 1/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67060-106-68

100 PACKET in 1 CARTON (67060-106-68) > 2 TABLET in 1 PACKET (67060-106-02)

• Marketing Start Date: 2015-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67060-106-67 [67060010667]

COLD TABS II TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-04-10
• Marketing End Date: 2016-10-25

NDC 67060-106-68 [67060010668]

COLD TABS II TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-04-10

NDC 67060-106-02 [67060010602]

COLD TABS II TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-10-25

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 1/1

OpenFDA Data

• SPL SET ID: cdbe0b3a-ced3-465c-92a1-a526bbd07f09
• Manufacturer:
  • ADVANCED FIRST AID, INC.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1243679

NDC Crossover Matching brand name "COLD TABS II" or generic name "Acetaminophen, Guaifenesin And Phenylephrine Hcl"

NDC	Brand Name	Generic Name
67060-106	COLD TABS II	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL
68210-4164	Non-Drowsy Daytime Severe Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
0363-0412	Non-Drowsy Wal-Phed PE Triple Relief	Acetaminophen, Guaifenesin and Phenylephrine HCl
0363-5270	Severe Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
63941-527	Severe Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
33992-0527	Severe Sinus Congestion and Pain Daytime	Acetaminophen, Guaifenesin and Phenylephrine HCl
15127-963	Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
49035-527	Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
55301-527	Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
55315-527	Sinus Congestion and Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
55910-527	Sinus Congestion And Pain	Acetaminophen, Guaifenesin and Phenylephrine HCl
11822-0527	Sinus Congestion and Pain Relief	Acetaminophen, Guaifenesin and Phenylephrine HCl
0363-5279	Sinus PE Pressure, Pain and Mucus	Acetaminophen, Guaifenesin and Phenylephrine HCl