NDC | 50201-4212-0 |
Set ID | 43c7f435-735c-3fab-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Tower Laboratories Ltd |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | PART343 |
- Active ingredients
- Purpose
- Uses
-
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 a nonsteroidal anti-inflammatory drug (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 non-prescription 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
- Ask a doctor before use if
- Ask a doctor of pharmacist before us if you are
- When using this product
-
Stop use and ask a doctor if
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 lasts for more than 10 days or gets worse
■ new symptoms occur
■ redness or swelling is present
■ ringing in the ears or a loss of hearing occurs
- If pregnant or breast-feeding
- Keep out of reach of children.
- OVERDOSAGE
-
Directions
■ do not exceed recommended dosage
■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking
■ adults and children 12 years and over (up to 60 yrs of age): 2 tablets every 4 hours - do not exceed 8 tablets in 24 hrs
■ 60 years and over: 2 tablets every 4 hours - do not exceed 4 tablets in 24 hours
- Other information
- Inactive ingredients
- ADVERSE REACTIONS
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TOP VALUE EFFERVESCENT PAIN RELIEF
apirin, citric acid, sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50201-4212 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1916 mg Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code L421 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50201-4212-0 10 in 1 CARTON 08/19/2014 1 2 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 12/01/2006 Labeler - Tower Laboratories Ltd (001587203)