Label: RAPID COMFORT EXTRA STRENGTH NON ASPIRIN- acetaminophen tablet, film coated
Contains inactivated NDC Code(s)
NDC Code(s): 60683-129-13, 60683-129-33
- Packager: Lab Safety Supply, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated October 14, 2011
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
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
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.
- 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.
- Other information
- Inactive ingredients
- Questions or comments? 1-800-356-0783
PRINCIPAL DISPLAY PANEL
175R LSS XS Non Aspirin 500 mg Label
Acetaminophen 500 mg
Easy to Swallow
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:60683-129 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60683-129-33 50 in 1 BOX, UNIT-DOSE 1 2 in 1 PACKET 2 NDC:60683-129-13 250 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)