RAPIDOL ASPIRIN- aspirin tablet, coated

Rapidol Aspirin by

Drug Labeling and Warnings

Rapidol Aspirin by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient and Purpose

.

• Active ingredient (in each tablet): Purpose
• Aspirin 325 mg (NSAID*)............................. *nonsteroidal anti-inflammatory drug: Pain reliever

Uses

Temporary relief of minor aches and pains due to:

• a cold
• headache
• backache
• muscular aches
• toothache
• minor pains from arthritis

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 severe allergic reactions which may include:

■ hives

■ facial swelling

■ shock

■ asthma (wheezing)

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, ibuproben, 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

■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

■ you have asthma ■ 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 take a diuretic

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug for 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

■ ringing in the ears or a loss of hearing occurs

■pain gets worse or last for more than 10 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present

■ any new symptoms appear

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 an overdose, get medical help or contact a Poison Control Center right away.

Directions

■adults and children 12 years of age and older:

■ drink a full glass of water with each dose

■ take one (1) or two (2) tablets every 4 hours, while symptoms persist

■ do not take more than 12 tablets in 24 hours, unless directed by a doctor

■children under 12 years of age: consult a doctor

Other information

• store between 68-77˚F (20-25˚C)

Inactive ingredients

corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions or comments?

Dist. by/ por: Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

(M-F) 9AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

RAPIDOL ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-363
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
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ASP325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-363-60	1 in 1 CARTON	08/01/2023
1		60 in 1 BOTTLE; 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	08/01/2023

Labeler - Pharmadel LLC (030129680)