MINIPRIN- aspirin tablet, coated
TIME CAP LABORATORIES, INC

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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49483-054 miniprin

In each tablets Aspirin 81 mg (NSAID*)

PAIN RELIEVER

INDICATIONS AND USAGE:

Pain Reliever – temporarily relieves minor aches and pains. For other uses, see your doctor. Do not use for more than 10 days without consulting your doctor because serious side effects may occur.

WARNINGS:

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product,, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include: facial swelling, shock, hives, asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescription NSAIDS(aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed.

DOSAGE AND ADMINISTRATION:

Drink a full glass of water with each dose. Adults and children 12 years and over; take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor. Children under 12 years; consult a doctor.

acetylated monoglycerides, anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-CYellow no.10 aluminum lake, hypromellose, hypromellose phthalate, iron oxide yellow (iron oxide ochre), microcrystalline cellulose, mineral oil, polyethylene glycol (PEG) 80, titanium dioxide

keep Out of the Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away

130label Enter section text here

MINIPRIN
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49483-054
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Ingredient Name	Strength
Inactive Ingredients
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	8
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49483-054-12	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/2012	12/14/2018
2	NDC:49483-054-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/2012	12/14/2018
3	NDC:49483-054-00	100000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/2012	12/14/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	05/07/2012	12/14/2018

Labeler - TIME CAP LABORATORIES, INC (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME CAP LABORATORIES, INC		037052099	manufacture(49483-054)

Revised: 12/2018

Document Id: 7d0234cb-e640-ae02-e053-2991aa0aa58f

Set id: f138af02-44da-45db-82c3-9d4df87b4de9

Version: 2

Effective Time: 20181214

TIME CAP LABORATORIES, INC