TOPCARE EFFERVESCENT PAIN RELIEF- aspirin tablet, effervescent

TopCare Effervescent Pain Relief by

Drug Labeling and Warnings

TopCare Effervescent Pain Relief by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each effervescent tablet)

Buffered aspirin 325 mg (NSAID)*

*Nonsteroidal anti-inflammatory drug

Purpose

(in each effervescent tablet)

Buffered aspirin 325 mg (NSAID)*. . . . . . . . . . Pain reliever/fever reducer

*Nonsteroidal anti-inflammatory drug

Uses

■ for the temporary relief of minor aches and pains due to:

■ headache ■ muscle pain ■ backache

■ toothache ■ menstrual pain ■ colds

■ minor arthritis pain

■ temporarily reduces fever

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 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 ■ take more or for a longer time than directed

Do not use

Do not use ■ if you are allergic to aspirin or any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to this product or any of its ingredients

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

Ask a doctor or pharmacist before use ifyou are taking a prescription drug for

■ diabetes ■ gout ■ arthritis

When using this product

When using this product do not exceed recommended dosage

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

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

■ ringing in the ears or a loss of hearing occurs

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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

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

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: 2 tablets every 4 hours, or as directed by a doctor - do not exceed 8 tablets in 24 hours

60 years and over: 2 tablets every 4 hours, or as directed by a doctor - do not exceed 4 tablets in 24 hours

children under 12 years: consult a doctor

Take this product any time – morning, noon or night – when you need relief from headaches, backaches, body aches or muscle pain.

Place two (2) tablets in 4 oz. of water. Dissolve tablets completely.

You do not have to drink any of the residue that may be on the bottom of the glass. The medicines are in the water.

Other information

■ each tablet contains: sodium 524 mg

■ store at room temperature (59º-86ºF). Avoid excessive heat.

Inactive ingredients

anhydrous citric acid, sodium bicarbonate

Questions or comments

Questions or comments? (1-888-423-0139)

Principal Display Panel

INGREDIENTS AND APPEARANCE

TOPCARE EFFERVESCENT PAIN RELIEF 
aspirin tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-789
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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: 36800-789-36	18 in 1 CARTON	11/16/2023
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 Drug	M013	11/16/2023

Labeler - TOPCO ASSOCIATES LLC (006935977)