Label: DAYTIME AND NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit
- NDC Code(s): 51013-196-02
- Packager: PuraCap Pharmaceutical LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 20, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each softgel)
- Purposes
- Uses
-
WARNINGS
Liver warning
These products contain acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for these products
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using these products
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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 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 (Nighttime 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)
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to an enlarged prostate gland
- glaucoma (Nighttime only)
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers (Nighttime only)
- taking the blood thinning drug warfarin
When using these products
- do not use more than directed
In addition, when using Nighttime:
- 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 or nasal congestion (Daytime only) gets worse or last more than 7 days
- redness or swelling is present
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough comes back, or occurs with rash, or headache that lasts.
These could be signs of a serious condition.
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Directions
- take only as directed - see Overdose warning
- Take Nighttime or Daytime
- do not exceed 4 doses per 24 hrs
Age Daytime Nighttime adults and children 12 yrs & over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor ask a doctor children under 4 yrs do not use do not use - When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
- Other information
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Inactive ingredients
Daytime: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink
Nighttime: D&C yellow # 10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink
- Questions or comments?
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INGREDIENTS AND APPEARANCE
DAYTIME AND NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51013-196 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51013-196-02 1 in 1 CARTON; Type 0: Not a Combination Product 07/12/2017 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 COLD AND FLU
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 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) SORBITAN (UNII: 6O92ICV9RU) 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 07/12/2017 Part 2 of 2 NIGHTTIME COLD AND FLU
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) SORBITAN (UNII: 6O92ICV9RU) 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 07/12/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/12/2017 Labeler - PuraCap Pharmaceutical LLC (962106329) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 421293287 manufacture(51013-196) , analysis(51013-196)