Label: PAIN RELIEF FAST RELIEF- aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 10, 2014
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.
Aspirin may cause a sever allergic reaction which may include:
- facial swelling
- asthma (wheezing)
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 other drugs containing prescription or nonprescription NSAID's (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for longer time than directed
If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers.
Do not use: if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
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
- you have a sodium-restricted diet
Ask a doctor or pharmacist before use if
- you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
- you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis.
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- 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
- symptoms get worse or last more than 10 days
- new symptoms occur
- redness or swelling is present
- ringing in the ears or a 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.
- Other information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 36 Tablet Carton
the lower price name brand
Aspirin (NSAID) / Pain reliever,
Citric acid / Antacid, Sodium bicarbonate / Antacid.
Heartburn • Acid Indigestion
• Sour Stomach with
• Body Aches
Compare to Active
INGREDIENTS AND APPEARANCE
PAIN RELIEF FAST RELIEF
aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-968 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 325 mg Citric Acid Monohydrate (UNII: 2968PHW8QP) (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 2 pieces Shape ROUND Size 25mm Flavor Imprint Code C11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15127-968-36 18 in 1 CARTON 1 2 in 1 PACKET; 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 10/23/2006 Labeler - Select Brand (043562370)