LOW DOSE ASPIRIN ENTERIC SAFETY COATED- aspirin tablet, delayed release
CARDINAL HEALTH
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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LEADER 328R
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Uses
- temporarily relieves minor aches and pains
- for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
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Each Tablet contains Aspirin 81 mg (NSAID)
*Nonsteroidal anti-inflamatory drug
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| Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscamellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide ochre, methacrylic acid, ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate |
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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, shock, 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 more or for a longer time than directed.
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| Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800 222-1222) right away.
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Directions
- 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
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LOW DOSE ASPIRIN
ENTERIC SAFETY COATED
aspirin tablet, delayed release |
| Product Information |
| Product Type | HUMAN OTC DRUG | Item Code (Source) | NDC: 70000-0203 |
| Route of Administration | ORAL |
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| Active Ingredient/Active Moiety |
| Ingredient Name | Basis of Strength | Strength |
| ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) | ASPIRIN | 81 mg |
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| Product Characteristics |
| Color | white (ENTERIC COATED PEACH) | Score | no score |
| Shape | ROUND | Size | 7mm |
| Flavor | | Imprint Code |
emobssed;upper;heart;lower;plain
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| Contains | |
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| Packaging |
| # | Item Code | Package Description | Marketing Start Date | Marketing End Date |
| 1 | NDC: 70000-0203-1 | 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product | 01/06/2017 | 12/27/2019 |
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| Marketing Information |
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part343 | 08/11/2010 | 12/27/2019 |
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| Labeler - CARDINAL HEALTH
(097537435)
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| Registrant - TIME CAP LABORATORIES, INC (037052099) |
| Establishment |
| Name | Address | ID/FEI | Business Operations |
| TIME CAP LABORATORIES, INC | | 037052099 | manufacture(70000-0203) |
CARDINAL HEALTH
