Extra Strength Pain Aid: Package Insert and Label Information

EXTRA STRENGTH PAIN AID- caffeine, acetaminophen and aspirin tablet
Hi-Tech Nutaceuticals, 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.

actives
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ask a doc
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ask a doc or pharm
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do not use
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keep out of reach
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Pregnant
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Purpose

Questions
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Stop Use
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When using
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Warnings
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more warnings
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Directions
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inactives
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Storage
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Indications
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PDP
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EXTRA STRENGTH PAIN AID
acetaminophen, aspirin, caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69732-006
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE (CAFFEINE) CAFFEINE 65 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
ASPIRIN (ASPIRIN) ASPIRIN 250 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM STARCH GLYCOLATE TYPE A
MAGNESIUM STEARATE
Product Characteristics
Color white Score score with uneven pieces
Shape ROUND Size 10mm
Flavor Imprint Code HT565
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69732-006-01 30 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/30/2020
Labeler — Hi-Tech Nutaceuticals, LLC (606221443)
Establishment
Name Address ID/FEI Operations
Hi-Tech Nutraceuticals, LLC 080787135 pack (69732-006)
Establishment
Name Address ID/FEI Operations
Hi-Tech Nuraceuticals, LLC 606221443 manufacture (69732-006)

Revised: 05/2020 Hi-Tech Nutaceuticals, LLC

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