SEVERE COLD MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Severe Cold Multi Symptom by

Drug Labeling and Warnings

Severe Cold Multi Symptom by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

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

Warnings

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.

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 aloholic drinks daily while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fevere, 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 are allergic to acetaminophen or any of the inactive ingredients in 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 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
• new symptoms occur
• fever gets worse, or lasts more than 3 days
• redness or swelling is present
• cough comes back, or occurs with fever, 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 recommneded 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.

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
• shake well before using
• adults and children 12 years of age and older: 30 mL every 4 hours
• children under 12 years of age: do not use

Other information

• each 30 mL contains: sodium 10 mg
• store at 20º-25ºC (68º-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, ethyl alcohol, FD&C blue 1, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

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

Principal Display Panel

Multi-Symptom Severe

Cold Relief 

Acetaminophen- Pain reliever, fever reducer

Dextromethorphan HBr-Cough suppressant

Guaifenesin-Expectorant

Phenylephrine HCl-Nasal decongestant

Relieves: headache, fever, sore throat, mucus, nasal congestion, coughing, chest congestion

Cool Mint Flavor

FL OZ (mL)

Alcohol 1%

For ages 12 & over

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Cold Multi-Symptom Severe Cool Burst®

DISTRIBUTED BY:

FAMILY DOLLAR SERVICES, INC.,

10401 MONROE RD

MATTHEWS, NC 28105 USA

FAMILYDOLLAR.COM

Package Label

Family Wellness Severe Cold Multi Symptom

INGREDIENTS AND APPEARANCE

SEVERE COLD MULTI SYMPTOM 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-001-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/31/2015	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/31/2015	12/30/2021

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)