Label: ACETAMINOPHEN (RED)- acetaminophen capsule, liquid filled
- NDC Code(s): 53345-010-02
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
- 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 November 5, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each capsule)
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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if the user has liver disease
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Do not take more than directed
(see Overdose 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
- Questions or Comments?
PRINCIPAL DISPLAY PANEL - Shipping Label
ACETAMINOPHEN CAPSULES, 325 mg
Quantity : 4000 Capsules
NDC. No : 53345-010-02
Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
INGREDIENTS AND APPEARANCE
acetaminophen capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-010 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 FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (Clear) Score no score Shape capsule (Oblong) Size 20mm Flavor Imprint Code PC17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-010-02 1 in 1 BOX 04/04/2016 1 4000 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 04/04/2016 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd 421293287 manufacture(53345-010) , analysis(53345-010)