MAXIMUM STRENGTH MAX COLD AND SINUS- acetaminophen, guaifenesin, phenylephrine hcl liquid

Maximum strength Max Cold and Sinus by

Drug Labeling and Warnings

Maximum strength Max Cold and Sinus by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients
(in each 20 mL)
Acetaminophen 650 mg
Guaifenesin 400 mg
Phenylephrine HCl   10 mg

PURPOSE

Purpose

Acetaminophen        Pain reliever/Fever reducer
Guaifenesin             Expectorant    
Phenylephrine HCl    Nasal decongestant

INDICATIONS & USAGE

Uses

temporarily relieves these common cold and flu symptoms:
nasal congestion
sinus congestion and pressure
minor aches and pains
sore throat
headache
fever
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

WARNINGS

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 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.
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
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma 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.

When using this product do not use more than directed

Stop use and ask a doctor if
nervousness, dizziness or sleeplessness occur
redness or swelling is present
symptoms do not get better within 7 days or are accompanied by a fever
fever gets worse or lasts more than 3 days
new symptoms occur
cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a
serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away.

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. Quick medical attention is critical for adults as well as for children even if
you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions
take only as recommended (see Overdose warning)
use dosage cup
mL =milliliter
do not take more than 6 doses in any 24-hour period

• Adults & children 12 years and older: 20 mL every 4 hours
• Children under 12 years of age: Do not use

OTHER SAFETY INFORMATION

Other information
each 20 mL contains: sodium 10 mg
dosage cup provided
store between IS-30°C (59-86°F)
do not refrigerate

INACTIVE INGREDIENT

Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate,
purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

QUESTIONS

Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

Maximum Strength MAX COLD & SINUS

AP SAFE                       NDC: 76281-515-25

Compare to Mucinex® FAST-MAX™ Cold & Sinus
Active ingredients*

Maximum Strength
MAX COLD & SINUS

Acetaminophen /
Pain reliever/Fever Reducer
Guaifenesin /Expectorant
Phenylephrine HCl / Nasal decongestant
Cold & Sinus

Relief of:
Fever & Bodyaches
Thins & Loosens Mucus
Nasal & Chest Congestion

Adults- For Ages 12 and over
6 FL OZ ( 177 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Failure to follow these warnings could result in serious consequences.

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

* This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold &
Sinus.

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INGREDIENTS AND APPEARANCE

MAXIMUM STRENGTH MAX COLD AND SINUS 
acetaminophen, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-515
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-515-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/30/2024

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-515)