ADULT LOW DOSE ENTERIC COATED ASPIRIN- aspirin tablet, coated

Adult Low Dose Enteric Coated Aspirin by

Drug Labeling and Warnings

Adult Low Dose Enteric Coated Aspirin by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 81 mg(NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• for the temporary relief of minor aches and pains
• ask your doctor about other uses for aspirin

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:

• hives
• facial swelling
• asthma (wheezing)
• shock

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

Do not use if your are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

• the stomach bleeding warning applies to you
• you are taking a diuretic
• you have a history of stomach problems, such as heartburn
• you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
• taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
• an allergic reaction occurs. Seek medical help right away
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• fever gets worse or lasts more than 3 days
• any new symptoms occur
• ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

ask a health professional before use. it is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

Directions

• drink a full glass of water with each dose
• swallow whole, do not chew or crush
  
• do not exceed recommended dose
• adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
• children under 12 years: ask a doctor

Other information

• store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
• for institutional use only

Inactive ingredients

cellulose, D &C yellow
#10, FD&C yellow #6, hypromellose, iron oxide,
methacrylic acid, PEG, polydextrose, propylene
glycol, silica, simethicone, sodium bicarbonate,
sodium lauryl sulfate, starch, talc, titanium dioxide,
triacetin, triethyl citrate, wax. May also contain:
acetylated monoglycerides, croscarmellose sodium,
hypromellose phthalate, lactose, mineral oil,
polysorbate 80, stearic acid.

PRINCIPAL DISPLAY PANEL

DRUG: Adult Low Dose Enteric Coated Aspirin

GENERIC: Aspirin

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-0928-0

NDC: 70518-0928-1

NDC: 70518-0928-2

NDC: 70518-0928-3

NDC: 70518-0928-4

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: L

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 28 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

• ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

• DIMETHICONE
• FERROSOFERRIC OXIDE
• SILICON DIOXIDE
• SODIUM BICARBONATE
• SHELLAC
• SODIUM LAURYL SULFATE
• TRIACETIN
• TALC
• TITANIUM DIOXIDE
• PROPYLENE GLYCOL
• D&C YELLOW NO. 10
• FD&C YELLOW NO. 6
• HYPROMELLOSES
• STARCH, CORN
• POLYETHYLENE GLYCOLS
• CELLULOSE, MICROCRYSTALLINE
• POLYDEXTROSE
• METHACRYLIC ACID
• TRIETHYL CITRATE

INGREDIENTS AND APPEARANCE

ADULT LOW DOSE ENTERIC COATED ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0928(NDC:57896-981)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHACRYLIC ACID (UNII: 1CS02G8656)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	L
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0928-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/04/2018
2	NDC: 70518-0928-1	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	09/17/2018
3	NDC: 70518-0928-2	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/29/2019
4	NDC: 70518-0928-3	100 in 1 BOX	11/04/2019
4	NDC: 70518-0928-4	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	01/04/2018

Labeler - REMEDYREPACK INC. (829572556)