NDC | 53345-026-01 |
Set ID | 7a28d0fe-0e0a-453a-b604-1cc784dd153c |
Category | HUMAN OTC DRUG LABEL |
Packager | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each capsule)
- Purpose
- Uses
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Warnings
Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warningIf sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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DO NOT USE
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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- To make a child sleep
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- STOP USE
- PREGNANCY OR BREAST FEEDING
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KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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Directions
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hours
adults and children 12 years of age and over
take 2 softgels with water every 6 hours children 4 to 12 years of age
ask a doctor children under4 years o9f age
do not use When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.
- Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - Shipping Label
NIGHTTIME COLD AND FLU CAPSULES
Quantity : 4000 Capsules
NDC. No : 53345-026-01IMPORTANT:
1.Inspect immediately upon receipt.
2.This is a bulk shipment, intended for further processing only.
3.Protect from heat, humidity, and light. Do not refrigerate.
4.Store at 15-30°C (59-86°F)CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING"
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INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-026 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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 green Score no score Shape CAPSULE (oblong) Size 21mm Flavor Imprint Code 660 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-026-01 1 in 1 BOX 08/11/2014 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 final part341 08/11/2014 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(53345-026) , ANALYSIS(53345-026)