NDC | 51013-124-02 |
Set ID | 52c36828-ea1f-4e71-ab1b-bc70f3c62f74 |
Category | HUMAN OTC DRUG LABEL |
Packager | PuraCap Pharmaceutical LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each softgel)
- Purpose
- Uses
-
Warnings
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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 (NiteTime only)
Ask a doctor before use if you have
- liver disease
- heart disease (DayTime only)
- thyroid disease (DayTime only)
- diabetes (DayTime only)
- high blood pressure (DayTime only)
- trouble urinating due to an enlarged prostate gland
- cough that occurs with excessive phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema, and (for NiteTime only) chronic bronchitis
- glaucoma (NiteTime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (NiteTime only)
When using this product
When using this product, do not use more than directed.
In addition, when using NiteTime:
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless (DayTime only)
- pain, cough and (for DayTime only) nasal congestion gets worse or last more than 7 days
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
-
Directions
- Take only as directed - see Overdose warning
- swallow whole; do not crush, chew, or dissolve
- do not exceed 4 doses per 24 hours
Age DayTime NiteTime adults and children 12 years of age and over take 2 softgels with water every 4 hours take 2 softgels with water every 6 hours children 4 to under 12 years of age ask a doctor ask a doctor children under 4 years of age do not use do not use When using other DayTime or NiteTime products, carefully read each label to ensure correct dosing
- Other information
-
Inactive ingredients
NiteTime: D&C yellow # 10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink
DayTime: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
DAYTIME AND NITETIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-124 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51013-124-02 1 in 1 CARTON; Type 0: Not a Combination Product 06/27/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 8 Part 2 1 BLISTER PACK 4 Part 1 of 2 DAYTIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filledProduct Information 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 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 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 orange (clear) Score no score Shape capsule (oblong) Size 20mm Flavor Imprint Code PC9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 8 in 1 BLISTER PACK; 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 06/27/2016 Part 2 of 2 NITETIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filledProduct Information 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 (clear) Score no score Shape capsule (oblong) Size 20mm Flavor Imprint Code PC10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 4 in 1 BLISTER PACK; 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 06/27/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/27/2016 Labeler - PuraCap Pharmaceutical LLC (962106329) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 421293287 manufacture(51013-124) , analysis(51013-124)