COLD AND SINUS MAXIUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hydrochloride liquid 
DeMoulas Market Basket

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Cold & Sinus 515

Drug Facts
Active ingredients
(in each 20 mL)

Acetaminophen 650 mg
Guaifenesin 400 mg
Phenylephrine HCL 10 mg

Purpose

Pain reliever/Fever reducer
Expectorant
Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

Warnings

Liver warning This product contains acetamnophen. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin reactions,
Symptoms may include:

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

Ask a doctor or pharmacist before use if you are

When using this product

stop use and ask a doctor if

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.

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

Age                                                  Dose

Adults & children                               20 mL every 4 hours
12 years and older

Children under 12                             Do not use
years of age

Other information

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 9:30 AM to 4:30 PM EST 1-877-798-5944

Cold and Sinus product label

Market Basket®
"MORE FOR YOUR MONEY"
* COMPARE TO
the active ingredients found in
MUCINEX® FAST-MAX™
COLD & SINUS

Cold & Sinus
MAXIUN STRENGTH

Acetaminophen


(Pain Reliever/Fever Reducer)

Guiafenesin (Expectorant)

Phenylephrine HCL
(Nasal Decongestant)

Relieves Fever & Body Aches
Thins & Loosens Mucus
Relieves Nasal & Chest Congestion

Adults For Ages 12 & Over

LF-009 Rev 01

6 FL OZ (177 mL)

Peel Corner to Read Completed Drug Facts and information

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Failure to follow these warnings could result in serious consequences.

DISTRIBUTED BY
DEMOULAS SUPERMARKETS INC.
875 East Street
TEWKSBURY, MA 01876

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

AptaMB ColdSinus 515

AptaMB ColdSinus 515 1

COLD AND SINUS  MAXIUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-515
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) PHENYLEPHRINE10 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53942-515-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/19/2013
Labeler - DeMoulas Market Basket (007869647)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(53942-515)

Revised: 12/2023
Document Id: b2c93822-291f-4839-a6fd-9b515a8965a9
Set id: 6e5ca8e1-5a03-4e77-b385-d44387fb3bfc
Version: 2
Effective Time: 20231229
 
DeMoulas Market Basket