Label: TOPCARE NITE TIME DAY TIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
- NDC Code(s): 36800-143-73, 36800-580-72
- Packager: Topco Associates 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 July 11, 2023
If you are a consumer or patient please visit this version.
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- Active ingredients (in each softgel) – Nitetime Cold & Flu
- Active ingredients (in each softgel) – Daytime Cold & Flu
- Purpose – Nitetime Cold & Flu
- Purpose – Daytime Cold & Flu
- Uses – Nitetime Cold & Flu
- Uses – Daytime Cold & Flu
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have – Nighttime Cold & Flu
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- liver disease
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- persistent or chronic cough as occurs with smoking, asthma, or emphysema
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- trouble urinating due to an enlarged prostate gland
Ask a doctor before use if you have – Daytime Cold & Flu
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- liver disease
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- diabetes
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- heart disease
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- high blood pressure
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- thyroid disease
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu
- •
- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu
taking the blood thinning drug warfarin
When using this product
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- excitability may occur, especially in children
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if – Nighttime Cold & Flu
- •
- pain or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Stop use and ask a doctor if – Daytime Cold & Flu
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- you get nervous, dizzy or sleepless
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- pain, nasal congestion or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
- •
- redness or swelling is present
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- new symptoms occur
- •
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions – Nitetime Cold & Flu
- Directions – Daytime Cold & Flu
- Other information
- Inactive ingredients – Nitetime Cold & Flu
- Inactive ingredients – Daytime Cold & Flu
- Questions or comments?
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Principal Display Panel - Daytime
SPECIAL VALUE! COMBINATION PACK
Top Care® health
COMPARE TO VICKS® DAYQUIL® COLD & FLU ACTIVE INGREDIENTS
MULTI-SYMPTOM RELIEF
Day Time Cold & Flu Relief
PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
NASAL DECONGESTANT - PHENYLEPHRINE HCl
• Headache, Fever, Sore Throat, Minor Aches & Pains
• Nasal Congestion
• Cough
Alcohol Free
Antihistamine Free
Non-Drowsy
actual size
32 SOFTGELS
Top Care® health
COMPARE TO VICKS® NYQUIL® COLD & FLU ACTIVE INGREDIENTS
MULTI-SYMPTOM RELIEF
Nite Time Cold & Flu Relief
PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
ANTIHISTAMINE - DOXYLAMINE SUCCINATE
• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sneezing, Runny Nose
• Cough
Alcohol Free
actual size
16 SOFTGELS
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INGREDIENTS AND APPEARANCE
TOPCARE NITE TIME DAY TIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-580 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-580-72 1 in 1 CARTON; Type 0: Not a Combination Product 04/29/2014 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 8 BLISTER PACK 16 Part 2 16 BLISTER PACK 32 Part 1 of 2 TOPCARE NITE TIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Item Code (Source) NDC:36800-143 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color GREEN (clear) Score no score Shape OVAL Size 20mm Flavor Imprint Code 056 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-143-73 8 in 1 CARTON 1 2 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 02/02/2014 Part 2 of 2 TOPCARE DAY TIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color ORANGE Score no score Shape OVAL Size 20mm Flavor Imprint Code L994 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16 in 1 CARTON 1 2 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 09/28/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/29/2014 Labeler - Topco Associates LLC (006935977)