FDA Label for Valumeds Aspirin
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHAMRACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Valumeds Aspirin Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Aspirin (NSAID)* 325 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Indications & Usage
- temporary relieves minor aches and pains due to:
- headache
- minor arthritis pain
- toothache
- menstrual pain
- colds
- or as recommended by a doctor
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
- shock
- facial swelling
- asthma (wheezing)
- 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.
Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding.
The chance is higher if you
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
Ask A Doctor Or Phamracist Before Use If You Are
taking a prescription drug for diabetis, gout or arthritis
Stop Use And Ask A Doctor If
- 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
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptom appear
- ringing in the ears or a loss of hearing occurs
These could be signs of a serious condition.
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.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222
Directions
- adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose.
- do not take more than 12 tablets in 24 hours unless directed by a doctor
- children under 12 years of age: ask a doctor
Other Information
- store below 25 0C (77 0F)
- Tampet Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken
Inactive Ingredient
corn starch, croscarmellose sodium,D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc,titanium dioxide, triethyl citrate
Questions Or Comments?
1(888)333-9792
Package Label.Principal Display Panel
VALUMEDS TM
Compare to the active ingredient in
ECOTRIN ® TABLETS*
REGULAR STRENGTH
ASPIRIN
PAIN RELIEVER (NSAID)
- SAFETY COATED
PROTECT AGAINST
STOMACH UPSET
500 TABLETS
* Please review the disclaimer below.