Label: RAPIDOL ASPIRIN DISPLAY 2X25- aspirin tablet, coated
- NDC Code(s): 55758-362-02, 55758-362-50
- Packager: Pharmadel LLC
- 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.
Drug Label Information
Updated August 10, 2022
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- Drug Facts
- Active ingredient and Purpose
- Uses
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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)
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescriptionNSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
- are age 60 or older
- have 3 or more alcoholic drinks everyday while using this product
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 not been drinking fluids
- you have lost a lot of fluid due to vomiting or diarrhea
- you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis
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
- pain persist, gets worse or last for more than 10 days
- ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
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Principal Display Panel
NDC 55758-312-50
NDC 55758-312-02
Rapidol
Aspirin/Aspirina
325 mg
Alivia Dolor (AINE*) Pain Reliever (NSAID*)
Relieves / Alivia
✓ Headaches/ Dolor de Cabeza
✓ Muscular Pain/ Dolores Musculares
✓ Minor Arthritis Pain/ Dolores de Artritis LevesSIN CAFEINA / CAFFEINE FREE
25 Sobres x 2 Tabletas 25 packets of 2 tablets each
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INGREDIENTS AND APPEARANCE
RAPIDOL ASPIRIN DISPLAY 2X25
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-362 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 STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE (UNII: FZ989GH94E) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TALC (UNII: 7SEV7J4R1U) 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:55758-362-50 25 in 1 CARTON 08/10/2022 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:55758-362-02 2 in 1 PACKET; Type 0: Not a Combination Product 08/10/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 08/10/2022 Labeler - Pharmadel LLC (030129680)