MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU- acetaminophe, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl tablets 
TIME CAP LABORATORIES,INC

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49483-726_Timely_Maximum strength Day cold & flu and Night severe cold & flu Tablets

Drug Facts

Active ingredients (in each caplet)
Day Cold & Flu

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg


Active ingredients (in each caplet)
Night Severe Cold & Flu

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Triprolidine HCl 1.25 mg

Purposes
Day Cold & Flu

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant


Purposes
Night Severe Cold & Flu

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Antihistamine

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

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.

Do not use

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 a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers (Night Severe Cold & Flu only)

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)

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

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 information

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 dioxide

Inactive 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 or Comments?

Call 1-877-290-4008

49483-726_Timely 40ct_IFC

MAXIMUM STRENGTH DAY COLD AND FLU AND NIGHT SEVERE COLD AND FLU 
acetaminophe, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl tablets kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-726
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-726-644 in 1 CARTON09/21/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 24   in 4 
Part 24 BLISTER PACK 16   in 4 
Part 1 of 2
MAXIMUM STRENGTH DAY COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablets tablet
Product Information
Item Code (Source)NDC:49483-733
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorred (Light red to red) Scoreno score
ShapeCAPSULE (Capsule shaped tablet) Size19mm
FlavorImprint Code D1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/21/2023
Part 2 of 2
MAXIMUM STRENGTH NIGHT SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl tablets tablet
Product Information
Item Code (Source)NDC:49483-734
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (Light golden yellow to Golden yellow) Scoreno score
ShapeCAPSULE (Capsule shaped tablet) Size19mm
FlavorImprint Code N1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/21/2023
Labeler - TIME CAP LABORATORIES,INC (037052099)
Registrant - TIME CAP LABORATORIES,INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-726)

Revised: 9/2023
Document Id: fff69901-965d-5372-e053-6394a90a29c2
Set id: fff69901-965c-5372-e053-6394a90a29c2
Version: 1
Effective Time: 20230918
 
TIME CAP LABORATORIES,INC