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

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Maximum strength Max Cold & Sinus

Drug Facts


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

Purpose

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

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

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.

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.

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.

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

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

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

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? 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.

6 Oz 515

res

MAXIMUM STRENGTH MAX COLD AND SINUS 
acetaminophen, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-515
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-515-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/30/2024
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-515)

Revised: 1/2024
Document Id: ca73e55a-9cf6-4629-9e2d-2c2c9f328ad2
Set id: 263dae13-5f92-4505-8bcc-e903d05b9a0c
Version: 1
Effective Time: 20240131
 
AptaPharma Inc.