AEROTAB PAIN RELIEVER- pain reliever tablet 
Aero Healthcare

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.

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AEROTAB Pain Reliever

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:

WARNINGS

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

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

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

Ask a doctor before use if you have liver disease.

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

Stop use and ask a doctor if

These could be signs of a serious condition.

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

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

Other Information

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

AEROTAB

Pain Reliever

fever reducer

Acetaminophen 500mg

Caffeine 65mg

Extra Strength

Relieves aches and pains

Fever reducer

2 per packet

25010050Pouch

AEROTAB PAIN RELIEVER 
pain reliever tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55305-127
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScorescore with uneven pieces
ShapeCAPSULESize17mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55305-127-0225 in 1 BOX11/01/2022
1NDC:55305-127-012 in 1 PACKET; Type 0: Not a Combination Product
2NDC:55305-127-0450 in 1 BOX11/01/2022
2NDC:55305-127-012 in 1 PACKET; Type 0: Not a Combination Product
3NDC:55305-127-05125 in 1 BOX11/01/2022
3NDC:55305-127-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2022
Labeler - Aero Healthcare (008186174)
Registrant - Aero Healthcare (008186174)

Revised: 3/2023
Document Id: f63cee1f-8c8b-19e9-e053-2a95a90a854e
Set id: f63cee1f-8c8a-19e9-e053-2a95a90a854e
Version: 1
Effective Time: 20230306
 
Aero Healthcare