NDC | 68071-3189-1, 68071-3189-2, 68071-3189-3, 68071-3189-5, 68071-3189-6, 68071-3189-9 |
Set ID | 4eb78632-dc64-5d99-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | NuCare Pharmaceuticals, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
temporarily relieves
- headache
- menstrual pain
- minor pain of arthritis
- muscle pain
- toothache
- pain and fever of colds
- 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 prodcut, 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.
Close - OTHER SAFETY INFORMATION
Allergy alert: Aspirin may cause a severe allergic reaction which may include
- hives
- facial swelling
- asthma (wheezing)
- shock
- OTHER SAFETY INFORMATION
Stomach bleeding warning: This prodcut 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 (ibuprofen, naproxen, or others)
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
Drug Facts continued on back of label
Close - DO NOT USE
- ASK DOCTOR
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 are taking a diuretic
- you have asthma
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
- under a doctor's care for any serious condition
- taking any other drug
- STOP USE
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasta more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or loss of hearing occurs
These could be sings of a serious condition
Close - PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use. It is especially imporant 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.
Close - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Close - Directions
DRINK A FULL GLASS OF WATER WITH EACH DOSE
- adults and children 12 years and over: 1-2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
croscarmellose sodium, D&C yellow #10 (Al-lake), FD&C yellow #6 (Al-lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, povidone, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide
Close - Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Ecotrin®.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
Close - INGREDIENTS AND APPEARANCE
ASPIRIN 325 MG EC
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3189(NDC:69618-015) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) METHACRYLIC ACID (UNII: 1CS02G8656) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code AP;110 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3189-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017 2 NDC:68071-3189-1 21 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017 3 NDC:68071-3189-5 25 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017 4 NDC:68071-3189-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017 5 NDC:68071-3189-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017 6 NDC:68071-3189-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 11/01/2015 Labeler - NuCare Pharmaceuticals, Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals, Inc. 010632300 repack(68071-3189)