ADULT COLD, FLU AND SORE THROAT- acteaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

adult cold, flu and sore throat by

Drug Labeling and Warnings

adult cold, flu and sore throat by is a Otc medication manufactured, distributed, or labeled by Mckesson. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves these common cold and flu symptoms:

• nasal congestion
• sinus congestion and pressure
• cough due to minor throat and minor bronchial irritation
• minor aches and pains
• sore throat
• headache
• temporarily reduces fever
• temporarily promotes nasal and/or sinus drainage
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes 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 maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic 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 fever, headache, rash, nausea, vomiting, consult a doctor promptly.
  

Do not use

• with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• for children under 12 years of age
• 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 persistent headache. 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. 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 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 20 mg
• store between 15-30oC(59-86oF)
• do not refrigerate
• dosing cup provided
  

Inactive ingredients

citric acid anhydrous, edetate disodium, FD and C blue 1, FD and C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

PDP

adult cold, flu and sore throat

multi-symptom

Calms headaches and fevers

Relives nasal and chest congestion,

Soothes cough,

Thins and loosens mucus

ACETAMINOPHEN

pain reliever/Fever reducer

DEXTROMETHORPHAN HBr

Cough Suppressant

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCl

Nasal Decongestant

For Ages 12 and Over

MAXIMUM STRENGTH

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

ADULT COLD, FLU AND SORE THROAT  
acteaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650   in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 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)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-080-36	177 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2012

Labeler - Mckesson (177667227)