BAYER RAPID RELIEF- aspirin/caffeine oral powder powder

Bayer Rapid Relief by

Drug Labeling and Warnings

Bayer Rapid Relief by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Aspirin 650 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to: headache muscle pain backache menstrual cramps minor pain of arthritis temporarily reduces feve

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.

Directions

adults and children 12 years and over: take contents of 1 powder pack every 6 hours. Dissolve powder on tongue, followed by a full glass of water. Do not exceed 4 powder packs in 24 hours. ● children under 12 years: consult a doctor

Other information

● phenylketonurics: contains phenylalanine 0.0017 mg per powder pack ● save carton for full directions and warnings ● Store between 20°- 25 °C (68°-77° F)

Inactive Ingredients

anhydrous citric acid, flavors, mannitol, neotame, sodium citrate monobasic, sucralose

Questions or comments?

1-800-331-4536 (Mon-Fri 9AM - 5PMEST)

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BAYER RAPID RELIEF 
aspirin/caffeine oral powder powder

Product 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)