NDC | 50201-4216-8 |
Set ID | 6157820d-465e-ea51-e053-2991aa0a847b |
Category | HUMAN OTC DRUG LABEL |
Packager | Tower Laboratories Ltd. |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | PART343 |
- Active ingredients
- Purpose
- Uses
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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 ■ 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 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
- Ask a doctor before use if
- Ask a doctor or pharmacist before use 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.
- In case of overdose
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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 years of age) - 2 tablets every 4 hours do not exceed 8 tablets in 24 hours
60 years and over - 2 tablets every 4 hours do not exceed 4 tablets in 24 hours
- Other information
- Inactive ingredients
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOOD SENSE EFFERVESCENT ANTACID AND PAIN RELIEF
aspirin, citric acid, sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50201-4216 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1916 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 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:50201-4216-8 18 in 1 CARTON 09/03/2019 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 02/11/2013 Labeler - Tower Laboratories Ltd. (001587203) Registrant - Tower Laboratories Ltd. (001587203) Establishment Name Address ID/FEI Business Operations Tower Laboratories Ltd. 869024500 manufacture(50201-4216) , pack(50201-4216) , label(50201-4216)