NDC | 36800-577-02 |
Set ID | e49d8d28-388a-4c1b-a8e3-41c6dc4b69f5 |
Category | HUMAN OTC DRUG LABEL |
Packager | TopCo Associates LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- temporarily relieves these common cold and flu symptoms:
- nasal congestion
- cough (DAY TIME SEVERE COLD ONLY)
- minor aches and pains
- headache
- sore throat
- runny nose and sneezing (NIGHT TIME COLD & FLU ONLY)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME SEVERE COLD ONLY)
- temporarily reduces fever
- temporarily relieves these common cold and flu symptoms:
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
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.
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.
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.
- with any other product containing diphenhydramine, even one used on skin (NIGHT TIME COLD & FLU ONLY)
- 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.
- for children under 12 years of age
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma (NIGHT TIME COLD & FLU ONLY)
- a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME COLD & FLU ONLY)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (DAY TIME SEVERE COLD ONLY)
- cough that occurs with too much phlegm (mucus) (DAY TIME SEVERE COLD ONLY)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (NIGHT TIME COLD & FLU ONLY)
When using this product
- do not use more than directed
- excitability may occur, especially in children (NIGHT TIME COLD & FLU ONLY)
- marked drowsiness may occur (NIGHT TIME COLD & FLU ONLY)
- alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME COLD & FLU ONLY)
- avoid alcoholic drinks (NIGHT TIME COLD & FLU ONLY)
- be careful when driving a motor vehicle or operating machinery (NIGHT TIME COLD & FLU ONLY)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- 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.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
-
Directions
- do not take more than directed (see Overdose warning)
- do not take Day Time and Night Time caplets at the same time
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and older: take 2 caplets every 4 hours
- children under 12 years of age: do not use
- Other information
-
Inactive ingredients
DAY TIME SEVERE COLD
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
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PRINCIPAL DISPLAY PANEL
For Ages 12+
Maximum Strength†
Daytime Nighttime
NDC 36800-577-02
TopCare® Health™
Compare to Mucinex® Fast-Max® Day Time Severe Cold & Night Time Cold & Flu Active Ingredients*
Maximum Strength†
Our Pharmacists Recommend
Mucus Relief Severe Cold Daytime
Daytime
Pain Reliever/Fever Reducer – Acetaminophen
Cough Suppressant – Dextromethorphan Hbr
Expectorant – Guaifenesin
Nasal Decongestant – Phenylephrine HCl
Day Caplet Relieves:
Aches, Fever & Sore Throat
Cough • Nasal & Chest Congestion
Thins & Loosens Mucus
20 Caplets Day
Cold & Flu Nighttime
Nighttime
Pain Reliever/Fever Reducer – Acetaminophen
Antihistamine – Diphenhydramine HCl
Nasal Decongestant – Phenylephrine HCl
Night Caplet Relieves:
Aches, Fever & Sore Throat
Nasal Congestion
Runny Nose & Sneezing
10 Caplets Night
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF SEVERE COLD DAYTIME COLD AND FLU NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-577 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-577-02 1 in 1 CARTON 07/31/2017 11/30/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 20 Part 2 1 BLISTER PACK 10 Part 1 of 2 ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coatedProduct 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (UNII: 2S7830E561) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 19mm Flavor Imprint Code AAA;1165 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 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 Part 2 of 2 ACETAMINOPHEN, DIPHENHYDRAMINE HYROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength COPOVIDONE (UNII: D9C330MD8B) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color blue Score no score Shape OVAL (capsule-shaped) Size 17mm Flavor Imprint Code AAA;1116 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 10 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/31/2017 11/30/2021 Labeler - TopCo Associates LLC (006935977)