SEVERE COLD AND FLU RELIEF DAYTIME- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Severe Cold and Flu Relief by

Drug Labeling and Warnings

Severe Cold and Flu Relief 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 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

• temporarily relieves common cold and flu symptoms:
  • nasal congestion
  • sinus congestion and pressure 
  • minor aches and pains
  • headache
  • fever 
  • sore throat
  • reduces swelling of nasal passages
  • cough due to minor throat and bronchial irritation
  • temporarily restores freer breathing through the nose
  • promotes nasal and or sinus drainage
  • helps loosen phlegn (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• adult take more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount
• child takes more than 4 doses (15 mL each) in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blistere
• 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 is 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.

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
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
• a sodium restricted diet

Ask a doctor or pharmacist before use if user is

taking the blood thinning drug warfarin

When using this product

do not take 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 5 days (children) or 7 days (adults)
• new symptoms occur 
• fever gets worse or lasts more than 3 days
• redness or swelling is present  
• 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 can cause serious 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 and for children even if you do not notice any signs or symptoms

Directions

• take only as directed (see overdose warning)
• do not take more than 4 doses in 24 hours
• measure only with dosing cup provided. Do not use any other dosing device
• mL = milliliter
• keep dosing cup with product
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

• adults and children12 years and over: 30 mL every 4 hours
• children 6 to under 12 years: 15 mL every 4 hours
• children 4 to under 6 years: ask a doctor
• children under 4 years: do not use

Other information

• each 15 mL contains: sodium 12 mg
• store between 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

citric acid, FD&C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate sodium chloride, sodium citrate, sorbitol sucralose, xanthan gum

Questions or comments?

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® DAYQUIL® SEVERE COLD & FLU*

MAX STRENGTH

Severe Cold & Flu Relief 

Acetaminophen (Pain Reliever/Fever reducer)

Dextromethorphan HBr (Cough suppressant)

Guaifenesin (Expectorant)

Phenylephrine HCI (Nasal decongestant)

Multi-Symptom Relief of:

• Headache, fever, sore throat, minor aches & pains
• Nasal / sinus congestion & sinus pressure
• Cough
• Chest congestion

Alcohol Free

Non-Drowsy

For Ages 6 Years & Over

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and DayQuil® are registered trademarks of The Procter & Gamble Company.

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

Product Label

FAMILY WELLNESS Max Strength Severe Cold & Flu Relief

INGREDIENTS AND APPEARANCE

SEVERE COLD AND FLU RELIEF  DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-415
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
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-415-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/31/2017

Labeler - Family Dollar (FAMILY WELLNESS) (024472631)