TOPCO TUSSIN CF MAX- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution 
Topco Associates LLC

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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Topco Associates LLC. Tussin CF Max Drug Facts

Active ingredients (in each 20 mL)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Phenylephrine HCl, USP 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves these symptoms occurring with a cold or flu:
cough due to minor throat and bronchial irritation
nasal congestion
sinus congestion and pressure
minor aches and pains
sore throat
headache
temporarily reduces fever
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 4,000 mg of acetaminophen in 24 hours
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.
if you have ever had an allergic reaction to this product or any of its ingredients

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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

you get nervous, dizzy or sleepless
pain, cough, or nasal congestion 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 5 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 15 mg
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, benzyl alcohol, edetate disodium, FD&C red #40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, triacetin, xanthan gum

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO ROBITUSSIN® MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM

COUGH COLD + FLU ACTIVE INGREDIENTS

NON-DROWSY

Tussin CF Max

Multi-Symptom Cough, Cold & Flu

PAIN RELIEVER/FEVER REDUCER-ACETAMINOPHEN

COUGH SUPPRESSANT-DEXTROMETHORPHAN HBr

EXPECTORANT-GUAIFENESIN

NASAL DECONGESTANT-PHENYLEPHRINE HCl

MAXIMUM STRENGTH

SEVERE

RELIEVES:

• Cough, Sore Throat

• Body Aches, Fever

• Nasal Congestion

• Chest Congestion

Adult

For Ages 12 & Over

4 FL OZ (118 mL)

7c1-88-tussin-cf-max
TOPCO TUSSIN CF MAX 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-707
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRIACETIN (UNII: XHX3C3X673)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-707-261 in 1 CARTON09/11/2017
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:36800-707-341 in 1 CARTON09/14/2017
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/11/2017
Labeler - Topco Associates LLC (006935977)

Revised: 8/2022
Document Id: 8dc443af-5f4e-4ff2-afd5-d051ebb13da1
Set id: 3825eca6-51fa-4dd1-bdb4-af65fe9085e3
Version: 4
Effective Time: 20220822
 
Topco Associates LLC