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

Cold and Sinus by

Drug Labeling and Warnings

Cold and Sinus by is a Otc medication manufactured, distributed, or labeled by DeMoulas Market Basket, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive 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:

• 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 acetamnophen. 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 product warfarin.

When using this product

• do not use more that 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 persistant 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.

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 han 6 doses in any 24-hour period

Age                                                  Dose

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

Children under 12                             Do not use
years of age

Other information

• each 20 mL contains: sodium 10 mg
• dosage cup provided
• store between 15-30 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 9:30 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

INGREDIENTS AND APPEARANCE

COLD AND SINUS  MAXIUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-515
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	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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-515-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/19/2013

Labeler - DeMoulas Market Basket (007869647)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(53942-515)