COUGH RELIEF ORANGE- dextromethorphan hydrobromide liquid 
EQUALINE (SuperValu)

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.

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Drug Facts

Active Ingredients

Dextromethorphan HBr USP 15 mg

Purpose

Dextromethorphan HBr USP.........................Cough suppressant

Warnings

Do Not Use

• if you are on a sodium-restricted diet
• 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

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking,
asthma or emphysema

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or is accompanied by
fever, rash or persistent headache. These could be signs of a serious
condition.

When using this product

• do not use more than directed

If pregnant or breast-feeding

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional assistance
or contact a Poison Control Center immediately.

Directions

• take recommended dosage or as directed by a doctor

age                                                                             dose
adults and children 12 years and over.................2 teaspoonfuls every 6-8 hours, not to exceed 4 doses in 24 hours
children 6 years to under 12 years........................1 teaspoonful every 6-8 hours, not to exceed 4 doses in 24 hours
children 4 years to under 6 years..........................do not use unless directed by a doctor
children under 4 years............................................do not use

Other Information

each teaspoon contains: sodium 6 mg
• store at controlled room temperature

Inactive Ingredients

citric acid, edetate disodium, flavor, glycerin,
high fructose corn syrup, hydroxyethyl cellulose,
polyethylene glycol 3350, propylene glycol,
purified water, sodium benzoate, sucralose,
sucrose, tragacanth, xanthan gum, yellow 6

Uses

temporarily relieves cough due to minor throat and bronchial
irritation as may occur with the common cold or inhaled irritants

Principal Display Panel

Equaline
Cough Suppressant
Dextromethorphan HBr
6-8 hour cough relief for children and adults
alcohol-free, orange flavor
see new dosing directions
4fl oz 118mL

Package Label

Dextromethorphan HBr

EQUALINE Cough Relief

COUGH RELIEF  ORANGE
dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-156
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
TRAGACANTH (UNII: 2944357O2O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (Orange Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-156-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/13/200903/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/13/200903/31/2017
Labeler - EQUALINE (SuperValu) (006961411)

Revised: 6/2017
 
EQUALINE (SuperValu)