Label: BAYER RAPID RELIEF- aspirin/caffeine oral powder powder
- NDC Code(s): 0280-0103-01, 0280-0103-02, 0280-0103-03
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 10, 2023
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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 • 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 ● 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 Ask a doctor or pharmacist before use if you are taking a prescription drug for ● gout ● diabetes ● 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 ● pain gets worse or lasts more than 10 days ● fever gets worse or lasts more than 3 days ● redness or swelling is present ● new symptoms occur ● ringing in the ears or a loss of hearing occurs 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, get medical help or contact a Poison Control Center right away.
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INGREDIENTS AND APPEARANCE
BAYER RAPID RELIEF
aspirin/caffeine oral powder powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 650 mg Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MANNITOL (UNII: 3OWL53L36A) NEOTAME (UNII: VJ597D52EX) MONOSODIUM CITRATE (UNII: 68538UP9SE) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0103-01 1 in 1 CARTON 01/13/2023 1 10 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0280-0103-02 1 in 1 CARTON 01/13/2023 2 20 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0280-0103-03 1 in 1 CARTON 01/13/2023 3 30 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/13/2023 Labeler - Bayer HealthCare LLC. (112117283)