Country: United States
Language: English
Source: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)
Tower Laboratories Ltd
ORAL
OTC DRUG
Aspirin 325 mg (NSAID)* . . . . . . . . . . . . . . . . . . . . . .Pain reliever Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid Sodium bicarbonate (heat-treated) 1916 mg . . . . ....Antacid *Nonsteroidal anti-inflammatory drug Uses for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body aches and pains) Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product. 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 a sodium-restricted die
OTC monograph final
TOP VALUE EFFERVESCENT PAIN RELIEF- APIRIN, CITRIC ACID, SODIUM BICARBONATE TABLET, EFFERVESCENT TOWER LABORATORIES LTD _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._ ---------- TOP VALUE EFFERVESCENT PAIN TABLETS ACTIVE INGREDIENTS (IN EACH EFFERVESCENT TABLET) Aspirin 325 mg (NSAID)* Citric acid 1000 mg Sodium bicarbonate (heat-treated) 1916 mg *Nonsteroidal anti-inflammatory drug PURPOSE Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid Sodium bicarbonate (heat-treated) 1916 mg . . . . ....Antacid *Nonsteroidal anti-inflammatory drug USES _USES _for the temporary relief of ■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body aches and pains) 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 mor Read the complete document