![ADULT LOW DOSE ASPIRIN ENTERIC COATED (ASPIRIN 81MG) TABLET, DELAYED RELEASE [PHARBEST PHARMACEUTICALS, INC.]](https://medic.hrt.org//dailymed/images/45e5bae9-22a7-4699-85ea-5b922af6b96d/Adult Low Dose Aspirin Enteric Coated Package Label.jpg)
| NDC | 16103-351-09, 16103-351-11 |
| Set ID | 45e5bae9-22a7-4699-85ea-5b922af6b96d |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Pharbest Pharmaceuticals, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredient (in each tablet)
- Purpose
- Uses
- for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headache or other symptoms needing immediate relief.
- ask your doctor about other uses for this product
- 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 you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
- you have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
taking a prescription drug for:
- gout
- diabetes
- 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
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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.
CloseKeep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
- Directions
- drink a full glass of water with each dose
CloseAdults 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 - Other information
- store at room temperature (15°-30°C)
- avoid excess heat and moisture
- Tamper Evident: do not use if safety seal under cap is broken or missing
- Inactive ingredients
croscarmellose sodium, D&C Yellow# 10 Lake, FD&C Yellow #6, hypromellose, lactose, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, starch, talc, titanium dioxide, triacetin, triethyl citrate
Close - Questions or comments?
- PRINCIPAL DISPLAY PANEL
PHARBEST
NDC 16103-351-11
Manufactured in the USA
*Compare to the actuve ingredient in Bayer® Low Dose
Adult Low Dose
Aspirin
ENTERIC COATED
81mg
Aspirin 81 mg
Pain Reliever (NSAID)
EA8
1000 TABLETS
Talk to you doctor or other healthcare provider before using this product for your heart.
Close
- INGREDIENTS AND APPEARANCE
ADULT LOW DOSE ASPIRIN ENTERIC COATED
aspirin 81mg tablet, delayed releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-351 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color yellow (YELLOW COLOR) Score no score Shape ROUND (ROUND TABLET) Size 7mm Flavor Imprint Code EA8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16103-351-09 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/20/2019 2 NDC:16103-351-11 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 02/20/2019 Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Registrant - Pharbest Pharmaceuticals, Inc. (557054835) CloseEstablishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc. 557054835 manufacture(16103-351) , pack(16103-351) , analysis(16103-351)