OTC Medication Information: CVS Severe Congestion and Pain Relief

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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 the active ingredients Maximum Strength* Mucinex® Sinus- Max® Severe Congestion & Pain**

NDC 63824-261-66

ADULT

Severe Congestion Pain Reliever

Acetaminophen – Pain Reliever
GUAIFENESIN – Expectorant
PHENYLEPHRINE HCl – Nasal Decongestant

MAXIMUM STRENGTH*

Multi-Symptom

Clears Sinus Congestion
Relieves Headache
Thins & Loosens Mucus

For Ages 12 Years & Over

6 FL OZ (180mL)

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

*Per 4- hour dose

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02985

© 2020 CVS/pharmacy

CVS.com

1-800-SHOP CVS

V-12431

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

CVS Sever Congestion Relief Acetaminophen
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg in 20 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
Anhydrous citric acid
Edetate disodium
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM CITRATE
PROPYLENE GLYCOL
PROPYL GALLATE
WATER
SODIUM BENZOATE
SORBITOL
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color BLUE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-717-06 180 mL in 1 BOTTLE None
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)

Revised: 06/2022 CVS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.