Label: ACETAMINOPHEN (RED) (acetaminophen- red - acetaminophen capsule liquid filled capsule, liquid filled
-
Contains inactivated NDC Code(s)
NDC Code(s): 55629-718-01, 55629-718-02 - Packager: One2zee Limited Liability Company
- 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.
Drug Label Information
Updated February 22, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product - ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Overdose warning
-
Directions
Do not take more than directed
(seeOverdose warning)adults and children 12 years and over - take 2 softgels every 4 to 6 hours while symptoms last
- do not take more than 10 softgels in 24 hours
- do not use for more than 10 days unless directed by a doctor
children 6-11 years - take 1 softgel every 4 to 6 hours while symptoms last
- do not take more than 5 softgels in 24 hours
- do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor - Other Information
- Inactive ingredients
-
PRINCIPAL DISPLAY PANEL - Shipping Label
ACETAMINOPHEN CAPSULES, 325 mg
Quantity : 48 Bags of 300 Capsules each
NDC. No : 55629-718-01Important:
1. Inspect immediately upon receipt
2. This is bulk shipment intended for further processing only
3. Store at controlled temperature of 59°F to 86°F (15°C to 30°C) avoid high humidity and excessive heat above 104°F (40°C) -
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN (RED)
acetaminophen (red) - acetaminophen capsule liquid filled capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55629-718 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE K30 (UNII: U725QWY32X) FD&C RED NO. 40 (UNII: WZB9127XOA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score no score Shape capsule (Oblong) Size 20mm Flavor Imprint Code 718 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55629-718-01 48 in 1 BOX 02/25/2019 1 NDC:55629-718-02 300 in 1 BAG; 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 02/25/2019 Labeler - One2zee Limited Liability Company (078656111) Registrant - One2zee Limited Liability Company (078656111) Establishment Name Address ID/FEI Business Operations Medgel Private Limited 677385498 manufacture(55629-718) , analysis(55629-718)