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

NIGHTTIME Cold and Flu Max Softgels MAXIMUM STRENGTH by

Drug Labeling and Warnings

NIGHTTIME Cold and Flu Max Softgels MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-732
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
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
Color	orange	Score	no score
Shape	OVAL ((oblong))	Size	16mm
Flavor		Imprint Code	106
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-732-24	2 in 1 CARTON	04/20/2022
1		12 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	04/20/2022

Labeler - TOPCO ASSOCIATES LLC (006935977)