AEROTAB NON-ASPIRIN- acetaminophen 500mg es tablet

AeroTab Non-Aspirin by

Drug Labeling and Warnings

AeroTab Non-Aspirin by is a Otc medication manufactured, distributed, or labeled by Aero Healthcare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Acteminophen 500 mg

PURPOSE

Pain reliever / fever reducer

USES

temporary relief of minor aches and pains associated with

• common cold
• headache
• toothache
• muscular aches
• backache
• arthritis
• menstrual cramps
• temporarily reduces fever

WARNINGS

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 4000 mg of acetaminophen in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Allergy Warning: 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.

DO NOT USE

Do not use

• if you are allergic to acetaminophen
• with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether 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

• symptoms do not improve
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present
• a rare sensitivity reaction occurs

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 accidental overdose, contact a doctor or 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

• take only as directed - see Overdose warning
• do not take more than 8 tablets in any 24 hour period
• do not use more than 10 days unless directed to do so by a doctor

Adults and children 12 years and over: take 2 tablets every 4 to 6 hours.

Children under 12 years of age: do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

OTHER INFORMATION

Tamper evident. Do not use if packet is torn, cut or opened. Store between 20°-25°C (68°-77°F). Read all warnings and directions before use.

INACTIVE INGREDIENTS

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

PRINCIPAL DISPLAY PANEL

AEROTAB

Non-Aspirin

acetaminophen 500mg

Fever reducer

Pain Reliever

Relieves aches

2 per packet

INGREDIENTS AND APPEARANCE

AEROTAB NON-ASPIRIN 
acetaminophen 500mg es tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55305-126
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55305-126-02	25 in 1 BOX	10/31/2017
1	NDC: 55305-126-01	2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 55305-126-04	50 in 1 BOX	10/31/2017
2	NDC: 55305-126-01	2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 55305-126-05	125 in 1 BOX	10/31/2017
3	NDC: 55305-126-01	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	10/31/2017

Labeler - Aero Healthcare (008186174)

Registrant - Aero Healthcare (008186174)