RAPID COMFORT EXTRA STRENGTH NON ASPIRIN- acetaminophen tablet, film coated

Rapid Comfort Extra Strength Non Aspirin by

Drug Labeling and Warnings

Rapid Comfort Extra Strength Non Aspirin by is a Otc medication manufactured, distributed, or labeled by Lab Safety Supply, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

• headache
• muscular aches
• minor arthritis pain
• common cold
• toothache
• menstrual cramps

For the reduction of fever.

Warnings

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

• more than 8 tablets 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

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor

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 using and ask a doctor if

• symptoms do not improve
• new symptoms occur
• pain or fever persists or gets worse
• redness or swelling is present

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Directions

• do not use more than directed

Adults and children: (12 years and older) Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Do not give this adult strength product to children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information

• store at room temperature 59º-86ºF (15º-30ºC)
• tamper-evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.

* may contain

Questions or comments? 1-800-356-0783

PRINCIPAL DISPLAY PANEL

175R LSS XS Non Aspirin 500 mg Label

Rapid Comfort™

Extra Strength

Non-Aspirin

Acetaminophen 500 mg

Easy to Swallow

Film-Coated Tablets

Pull to Open

Compare active ingredient to:

Extra Strength Tylenol®

Registered Trademark of McNeil Consumer Products

See new warnings information

100 Tablets (50 x 2s)

Tamper-Evident Unit Dose Packets

INGREDIENTS AND APPEARANCE

RAPID COMFORT EXTRA STRENGTH NON ASPIRIN 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60683-124
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
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60683-124-33	50 in 1 BOX, UNIT-DOSE
1		2 in 1 PACKET
2	NDC: 60683-124-13	250 in 1 BOX, UNIT-DOSE
2		2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/14/2011

Labeler - Lab Safety Supply, Inc. (042851410)