Solves - Aspirin
FDA Label NDC 62309-779

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pace Wellness Inc. for the product Solves - Aspirin (NDC 62309-779). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each strip), purposes, uses, reye's syndrome, otc - when using, allergy alert, stomach bleeding warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

DO NOT USE IF SEALED POUCH IS OPEN, TORN, OR BROKEN

Distributed by: Pace Wellness Inc.
2040 S Alma School RD STE1, 474
Chandler, AZ 85286-0987

Active Ingredient (In Each Strip)

Aspirin 81mg (NSAID)

nonsteroidal anti-inflammatory drug

Purposes

Pain Reliever

Uses

for temporary relief of minor aches and pains or as recommended by your doctor. Ask your doctor about other uses for Solves Strips 81mg aspirin.

Reye's Syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.

Otc - When Using

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), and shock.

Stomach Bleeding Warning

This product contains an 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 or take more or for a longer time than directed.

Otc - Do Not Use

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

Otc - Ask Doctor

Ask a doctor before use if stomach bleeding warning applies to you, you have a history of stomach problems, such as heartburn, you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic, you have asthma or had a tonsillectomy or oral surgery in the last 7 days.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes, arthritis or anticoagulation.

Otc - Stop Use

Stop and ask a doctor if an allergic reaction occurs (seek medical help right away), if you experience any of the following signs of stomach bleeding (feel faint, vomit blood, have bloody or black stools, stomach pain that does not get better), pain gets worse or lasts more than 10 days, fever lasts more than 3 days, redness or swelling is present, new symptoms occur, ringing in the ears or loss of hearing occurs.

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take this medication by mouth. Take each dose with a full glass of water unless your doctor tells you otherwise. Adults and children 12 years and over: take 4 to 6 strips every 4 hours not to exceed 36 strips in a 24 hour period unless directed by a doctor. Children under 12: consult a doctor.

Other Information

store at room temperature.

Inactive Ingredients

Acesulfame Potassium, Cocoa Butter, Glycerin, Lecithin (soy), Microcrystalline Cellulose, Natural and Artificial Flavors, Pectin, Polysorbate 20, Sucralose, Water.

Questions?

Call 1-855-7Solves or www.SolvesStrips.com
You may also report serious side effects to this phone number

Principal Display Panel - 5 Strip Pouch

NDC 62309-779

The evolution of wellness

ZIPPER

solves
strips

Wild Cherry Flavor
Artificially Flavored

ASPIRIN REGIMEN

aspirin81mg Low Dose

(NSAID) PAIN RELIEVER

Dissolves Quickly • Tastes Great • Easy to Take

DISSOLVABLE ORAL STRIPS 5 STRIPS

Principal Display Panel (5 Strip Pouch)

Principal Display Panel (5 Strip Pouch)

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