SEVERE COLD AND MUCUS- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin liquid

Severe Cold and Mucus by

Drug Labeling and Warnings

Severe Cold and Mucus by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, LLC, Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

• for the temporary relief of the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough 
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily reduces fever

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 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.
• if you have ever had an allergic reaction to this product or any of its ingredients

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 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 exceed recommended dose

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: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt 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)
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
• mL = milliliter

• adults and children 12 years and over:
  • take 30 mL in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL in 24 hours, unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• each 15 mL contains: sodium 5 mg
• store at 20-25˚C (68-77˚F). Do not refrigerate.
• do not use if printed shrinkband is missing or broken.
• see back label for lot number and expiration date

Inactive ingredients

alcohol, anhydrous citric acid, FD & C blue no.1, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.

Questions or Comments?

1-888-309-9030

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
100% SATISFACTION GUARANTEED!
(888) 309-9030

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (240 mL Bottle)

DGTM| health

Compare to the active ingredients of Tylenol® Cold + Mucus Severe*

Severe
Cold & Mucus
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
Guaifenesin - Expectorant

For Adults 

• Head + Body Aches
• Fever + Sore Throat
• Cough
• Nasal Congestion
• Mucus + Chest Congestion

Cool Blast Flavor

ALCOHOL 0.5%
8 FL OZ (240 mL)
DO NOT USE IF PRINTED SHRINKBAND IS MISSING OR BROKEN.

INGREDIENTS AND APPEARANCE

SEVERE COLD AND MUCUS 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-995
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PEPPERMINT (UNII: V95R5KMY2B)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	BLUE (Blue to greenish blue)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-995-20	1 in 1 CARTON	03/04/2016
1		240 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/04/2016

Labeler - Dolgencorp, LLC (068331990)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(55910-995)