DRX CHOICE MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT- acetaminophen, dextromethorphan hbr solution 
RARITAN PHARMACEUTICALS

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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DRx Choice® Maximum Strength Severe Cough+ sore throat Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Uses

temporarily relieves these symptoms occurring with a cold or flu:
cough due to minor throat and bronchial irritation
minor aches and pains
sore throat
headache
temporarily reduces fever

Warnings

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

more than 6 doses in any 24 hours period, which is the maximum daily amount
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

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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

liver disease
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking any other pain reliever/fever reducer

When using this product do not use more than directed.

Stop use and ask a doctor if

pain 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 6 doses in any 24-hour period
do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
measure only with dosing cup provided
keep dosing cup with product
mL = milliliter
this adult product is not intended for use in children under 12 years of age

Age

dose

adults and children 12 years and over

20 mL every 4 hours

children under 12 years

do not use

Other information

each 20 mL contains: sodium 10 mg
store at room temperature Do not refrigerate.

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red No 40, glycerin, menthol, flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

Principal Display Panel

Compare to active ingredients in Robitussin® Maximum Strength Severe Cough + Sore Throat CF MAX*

NDC 68163-749-08

DRx Choice®

maximum strength

SEVERE

cough + sore throat

Acetaminophen (Pain reliever / Fever reducer)

Dextromethorphan HBr (Cough Suppressant)

Relieves:

Cough
Sore throat pain

For Ages 12 Years & over

No added Sugar
No added Alcohol

Strong Cooling Liquid

8 FL OZ (237 mL)

*This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Robitussin® Maximum Strength Severe Cough + Sore Throat CF MAX.

Maximum Strength claim based on maximum levels of active ingredients per dose.

IMPORTANT: Keep this carton for future reference on full labeling.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court, East Brunswick

NJ, 08816

DRx Choice Max Strength SEVERE cough + sore throat
DRX CHOICE MAXIMUM STRENGTH SEVERE  COUGH PLUS SORE THROAT
acetaminophen, dextromethorphan hbr solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-749
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-749-081 in 1 CARTON04/24/2023
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/24/2023
Labeler - RARITAN PHARMACEUTICALS (127602287)

Revised: 5/2023
Document Id: a096cb76-0d1c-4ca8-854a-5199da0bc8f7
Set id: a096cb76-0d1c-4ca8-854a-5199da0bc8f7
Version: 1
Effective Time: 20230511
 
RARITAN PHARMACEUTICALS