CVS SEVERE CONGESTION AND PAIN RELIEF- acetaminophen, guaifenesin, and phenylephrine hydrochloride solution

CVS Severe Congestion and Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 mL)	Purposes
Acetaminophen 650 mg	Pain reliever
Guaifenesin 400 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal decongestant

Uses

• ▪ temporarily relieves:
  • ▪ nasal congestion
  • ▪ headache
  • ▪ minor aches and pains
  • ▪ sinus congestion and pressure
• ▪ temporarily promotes nasal and/or sinus drainage
• ▪ helps loosens 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 6 doses in 24 hours, which is the maximum daily amount
• ▪ 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.
• ▪ 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
• ▪ high blood pressure
• ▪ thyroid disease
• ▪ diabetes
• ▪ trouble urinating due to an enlarged prostate gland
• ▪ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, 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
• pain, nasal congestion, or cough gets worse or lasts more than 7 days
• fever gets worse or lasts 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 right away at 1-800-222-1222. 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 dosing cup with other products
• ▪ dose as follows or as directed by a doctor
• ▪ adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
• ▪ children under 12 years of age: do not use

Other information

• ▪ each 20 mL contains: sodium 8 mg
• ▪ store at room temperature
• ▪ do not refrigerate

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue no. 1, FD&C Red no. 40, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label

Compare to Maximum Strength Mucinex®Sinus-Max® Severe Congestion & Pain Active Ingredients†

NDC: 63824-261-66

Maximum Strength*

Severe Congestion
& Pain Relief

Acetaminophen – Pain Reliever
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

• Clears Sinus Congestion
• Relieves Headache
• Thins & Loosens Mucus

6 FL OZ (180mL)For Ages 12+

Tamper evident: Do not use if printed inner seal under cap is broken or missing.

*Per 4- hour dose

Distributed by:

*This product is not manufactured or distributed by RB Health, the distributor of Maximum Strength* Mucinex® Sinus-Max® Severe Congestion & Pain.

INGREDIENTS AND APPEARANCE

CVS SEVERE CONGESTION AND PAIN RELIEF 
acetaminophen, guaifenesin, and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-717
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)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
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: 69842-717-06	180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/30/2020

Labeler - CVS (062312574)