NIGHTTIME COLD AND FLU MAX SOFTGELS MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled 
TOPCO ASSOCIATES LLC

----------

NIGHTTIME



Cold and Flu Max

Softgels



MAXIMUM STRENGTH

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

• temporarily relieves these symptoms due to a cold or flu:
• minor aches and pains
• headache
• cough
• sore throat
• nasal and sinus congestion
• temporarily reduces fever

Warnings

Liver warning:

This product contains acetaminophen.
Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Allergy alert:

Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
• skin reddening
• blisters
• rash n hives
• facial swelling
• asthma (wheezing)
• shock
If a skin or general allergic 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 to sedate children.

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.
• if you have ever had an allergic reaction to this product or any of its ingredients
• in children under 12 years of age

Ask a doctor before use if you have

• liver disease n heart disease n high blood pressure
• thyroid disease n diabetes
• cough with excessive phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• may cause marked drowsiness n avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• n excitability may occur, especially in children

Stop use and ask a doctor if

• pain, cough, or nasal congestion 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.
• nervousness, dizziness, or sleeplessness occurs
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 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 the recommended dose
• adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
• children under 12 years: do not use

Other information

• store at room temperature. Avoid temperatures above 25°C (77°F).

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, pearlin silver, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide

Questions or comments?

1-888-423-0139

Carton

TopCare health

NDC 36800-732-24

COMPARE TO ALKA-SELTZER® PLUS®
MAXIMUM STRENGTH NIGHTTIME COLD & FLU
POWERMAXTM GELS ACTIVE INGREDIENTS


NIGHTTIME

Cold & Flu Max Softgels
MAXIMUM STRENGTH

PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN

COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr

ANTIHISTAMINE - DOXYLAMINE SUCCINATE 

NASAL DECONGESTANT - PHENYLEPHRINE HCl


RELIEVES:
• Nasal Congestion
• Cough
• Headache & Body Ache
• Sore Throat
• Runny Nose

•Smaller Capsule •Same Strength

24SOFTGELS**
**Liquid-Filled Capsules

Carton

Carton

NIGHTTIME COLD AND FLU MAX SOFTGELS MAXIMUM STRENGTH 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-732
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeOVAL ((oblong)) Size16mm
FlavorImprint Code 106
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-732-242 in 1 CARTON04/20/2022
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/20/2022
Labeler - TOPCO ASSOCIATES LLC (006935977)

Revised: 12/2023
Document Id: 0c070058-9e21-cc8c-e063-6394a90ad801
Set id: 657b3898-1069-4f25-87ec-34c1b77ef3ac
Version: 4
Effective Time: 20231208
 
TOPCO ASSOCIATES LLC