TENSION HEADACHE RELIEF- acetaminophen, caffeine tablet
Hi-Tech Nutraceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TENSION HEADACHE RELIEF
acetaminophen, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69732-007
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	HT565
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69732-007-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/09/2020

Labeler - Hi-Tech Nutraceuticals, LLC (606221443)

Registrant - Hi-Tech Nutraceuticals, LLC (606221443)

Name	Address	ID/FEI	Business Operations
Establishment
Hi-Tech Nutraceuticals, LLC		080787135	pack(69732-007)

Name	Address	ID/FEI	Business Operations
Establishment
Hi-Tech Nutraceuticals, LLC		606221443	manufacture(69732-007)