68210-0019 : Tension Headache Relief Oral Tablet

NDC:	68210-0019
Labeler:	Spirit Pharmaceuticals LLC
Product Type:	Human OTC Drug
Drug Name:	Tension Headache Relief
Dosage Form:	Oral Tablet
Application #:	part343
Rev. Date:	Mar 16, 2018

Appearance:

Markings:	S431
Shapes:	Oval
Colors:	Red
Size (mm):	18
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 68210-0019-1: 1 BOTTLE, PLASTIC IN 1 CARTON (68210‑0019‑1) > 15 TABLET IN 1 BOTTLE, PLASTIC
• 68210-0019-2: 1 BOTTLE, PLASTIC IN 1 CARTON (68210‑0019‑2) > 24 TABLET IN 1 BOTTLE, PLASTIC

Active Ingredients:

• Acetaminophen
• Caffeine

Inactive Ingredients:

• Silicon Dioxide
• Croscarmellose Sodium
• D&c Red No. 27
• Fd&c Blue No. 2
• Fd&c Yellow No. 6
• Magnesium Stearate
• Microcrystalline Cellulose
• Polyethylene Glycol, Unspecified
• Polyvinyl Alcohol, Unspecified
• Povidone K30
• Starch, Pregelatinized Corn
• Water
• Stearic Acid
• Talc
• Titanium Dioxide /

Pharmaceutical Classes:

• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]
• Methylxanthine [EPC]
• Xanthines [CS]

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