Label: MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU- acetaminophe, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl tablets kit
- NDC Code(s): 49483-726-64
- Packager: TIME CAP LABORATORIES,INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 18, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
Uses
Day Cold & Flu
• temporarily relieves these common cold and flu symptoms:
o cough
o nasal congestion
o minor aches and pains
o sore throat
o headache
o stuffy nose
o sinus congestion and pressure
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Night Severe Cold & Flu
• temporarily relieves these common cold and flu symptoms:
o cough
o nasal congestion
o minor aches and pains
o sore throat
o headache
o sneezing
o sinus congestion and pressure
o runny nose
o itching of the nose or throat
o itchy, watery eyes due to hay fever
• temporarily reduces fever
• controls cough to help you get to sleep
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4,000 mg 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.
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DO NOT USE
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.
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ASK DOCTOR
Ask a doctor before use if you have
• liver disease
• heart disease
• diabetes
• high blood pressure
• thyroid disease
• glaucoma (Night Severe Cold & Flu only)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis (Night Severe Cold & Flu only)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)
- ASK DOCTOR/PHARMACIST
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WHEN USING
When using this product
• do not use more than directed
• excitability may occur, especially in children (Night Severe Cold & Flu only)
• marked drowsiness may occur (Night Severe Cold & Flu only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only)
• avoid alcoholic drinks (Night Severe Cold & Flu only)
• use caution when driving a motor vehicle or operating machinery (Night Severe Cold & Flu only)
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STOP USE
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 fever, rash, or headache that lasts. These could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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OVERDOSAGE
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.
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DOSAGE & ADMINISTRATION
Directions
Day Cold & Flu
• do not take more than directed (see Overdose warning)
• do not take more than 12 caplets in any 24-hour period
• adults and children 12 years of age and over: take 2 caplets every 4 hours
• children under 12 years of age: do not use
Night Severe Cold & Flu
• do not take more than directed (see Overdose warning)
• do not take more than 8 caplets in any 24-hour period
• adults and children 12 years of age and over: take 2 caplets every 4 hours
• children under 12 years of age: do not use
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients Day Cold & Flu
colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxideInactive ingredients Night Severe Cold & Flu
colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU
acetaminophe, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl tablets kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-726 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-726-64 4 in 1 CARTON 09/21/2023 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 BLISTER PACK 24 in 4 Part 2 4 BLISTER PACK 16 in 4 Part 1 of 2 MAXIMUM STRENGTH DAY COLD AND FLU
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablets tabletProduct Information Item Code (Source) NDC:49483-733 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg 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 Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color red (Light red to red) Score no score Shape CAPSULE (Capsule shaped tablet) Size 19mm Flavor Imprint Code D1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 6 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 Drug M012 09/21/2023 Part 2 of 2 MAXIMUM STRENGTH NIGHT SEVERE COLD AND FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl tablets tabletProduct Information Item Code (Source) NDC:49483-734 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 1.25 mg Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color yellow (Light golden yellow to Golden yellow) Score no score Shape CAPSULE (Capsule shaped tablet) Size 19mm Flavor Imprint Code N1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Drug M012 09/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/21/2023 Labeler - TIME CAP LABORATORIES,INC (037052099) Registrant - TIME CAP LABORATORIES,INC (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(49483-726)