AEROTAB PAIN RELIEVER- pain reliever tablet

Aerotab Pain Reliever by

Drug Labeling and Warnings

Aerotab Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Aero Healthcare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients (per tablet)

Acetaminophen 500mg

Caffeine 65mg

PURPOSE

Acetaminophen 500mg.............Pain Reliever / Fever Reducer

Caffeine 65mg...........................Pain Reliever Aid

USES

Temporarily relieves minor aches and pains due to:

• headaches
• muscular aches

WARNINGS

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionaly, rapid heartbeat.

DO NOT USE

Do not use

• if you are allergic to ascetaminophen
• with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure wheter a drug contains acetaminophen, ask a doctor or pharmacist.

ASK DOCTOR

Ask a doctor before use if you have liver disease.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

STOP USE

Stop use and ask a doctor if

• ​any new symptoms occur
• painful area is red or swollen
• pain gets worse or lasts form ore than 10 days
• fever gets worse or lasts for more than 3 days.

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

DIRECTIONS

• do not use more than directed
• adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
• children under 12 years: ask a doctor

Other Information

• Store at 20-25 C (68-77 F)
• do not use of pouch is torn or open

Inactive Ingredients

corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide.

Questions or comments?

Call 1-845-618-7037

PRINCIPAL DISPLAY PANEL

AEROTAB

Pain Reliever

fever reducer

Acetaminophen 500mg

Caffeine 65mg

Extra Strength

Relieves aches and pains

Fever reducer

2 per packet

INGREDIENTS AND APPEARANCE

AEROTAB PAIN RELIEVER 
pain reliever tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55305-127
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 2S7830E561)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	red	Score	score with uneven pieces
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55305-127-02	25 in 1 BOX	11/01/2022
1	NDC: 55305-127-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 55305-127-04	50 in 1 BOX	11/01/2022
2	NDC: 55305-127-01	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 55305-127-05	125 in 1 BOX	11/01/2022
3	NDC: 55305-127-01	2 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	11/01/2022

Labeler - Aero Healthcare (008186174)

Registrant - Aero Healthcare (008186174)