SINUS RELIEF SEVERE CONGESTION MAXIMUM STRENGTH- acetaminophen, guaifenesin, phenylephrine hcl liquid

Sinus Relief Severe Congestion by

Drug Labeling and Warnings

Sinus Relief Severe Congestion by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Acetaminophen 650 mg 

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever

Expectorant

Nasal decongestant

Uses

• temporarily relieves
  • headache
  • nasal congestion
  • minor aches and pains
  • sinus congestion and pressure
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive 

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 daily 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.

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. 
• for children under 12 years of age
• 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.

Ask a doctor before use if you have

• liver disease
• heart disease
• diabetes
• thyroid disease
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough that occur 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
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or last 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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 (1-800-222-1222) 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 directed (see Overdose warning)
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided. Do not use any other dosing device.
• keep dosing cup with product
• mL=milliliter
• adults and children 12 years and older: 20 mL every 4 hours
• dose as follows or as directed by a doctor
• children under 12 years of age: do not use

Other information

• each 20 mL contains: sodium 12 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to  the active ingredients in Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief*

ADULT

Severe Congestion Relief

ACETAMINOPHEN - Pain reliever

GUAIFENESIN - Expectorant

PHENYLEPHRINE HCI - Nasal decongestant

MAXIMUM STRENGTH

Multi-Symptom

• Clear sinus congestion
• Relieves headache
• Thins & loosens mucus

For Ages 12 & Over

FL OZ (mL)

*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® SINUS-MAX® Severe Congestion Relief.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com

Package Label

CVS HEALTH Severe Congestion Relief

INGREDIENTS AND APPEARANCE

SINUS RELIEF SEVERE CONGESTION  MAXIMUM STRENGTH
acetaminophen, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-478
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)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-478-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/30/2018

Labeler - CVS Pharmacy (062312574)