![TOPCARE NITE TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]](https://medic.hrt.org//dailymed/images/1f6e33ed-8766-4ee2-8138-30064082b609/image-01.jpg)
| NDC | 36800-560-62 |
| Set ID | 1f6e33ed-8766-4ee2-8138-30064082b609 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Topco Associates LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
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Uses
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- temporarily relieves common cold/flu symptoms:
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- nasal congestion
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- sinus congestion and pressure
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- cough due to minor throat and bronchial irritation
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- cough to help you sleep
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- minor aches and pains
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- headache
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- fever
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- sore throat
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- runny nose and sneezing
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- reduces swelling of nasal passages
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- temporarily restores freer breathing through the nose
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- promotes nasal and/or sinus drainage
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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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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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
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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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
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When using this product
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- do not use more than directed
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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
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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
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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.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
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Inactive ingredients
crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide
- Questions or comments?
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Package/Label Principal Display Panel
COMPARE TO VICKS® NYQUIL® SEVERE ACTIVE INGREDIENTS
MAXIMUM STRENGTH RELIEF
Nite Time Cold & Flu
OUR PHARMACISTS RECOMMEND
SEVERE
PAIN RELIEVER – FEVER REDUCER – ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
ANTIHISTAMINE - DOXYLAMINE SUCCINATE
NASAL DECONGESTANT - PHENYLEPHRINE HCl
Headache, Fever, Sore Throat, Minor Aches & Pains
Nasal/Sinus Congestion & Sinus Pressure
Sneezing, Runny Nose ● Cough
actual size
24 CAPLETS
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INGREDIENTS AND APPEARANCE
TOPCARE NITE TIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-560 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 19mm Flavor Imprint Code L5Y5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-560-62 12 in 1 CARTON 07/30/2015 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 07/30/2015 Labeler - Topco Associates LLC (006935977)
