TUSSIN CF- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid 
AptaPharma Inc.

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Drug Facts


Active ingredients
(in each 5 mL tsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCL, USP 5 mg

Purpose
Dextromethorphan HBr USP ........Cough Suppressant
Guailenesin USP ..........................Expectorant
Phenylephrine HCI, USP ...............Nasal Decongestant

Uses
■ helps loosen phlegm (mucus) and thin bronchial
   secretions to drain bronchial tubes
■ temporarily relieves these symptoms occurring with
   a cold:

Warnings
Do not use ■ if you are now taking aprescription
monoamine oxidase inhibitor (MAOI) (certain drugs
for depression, psychialric or emotional conditions or
Parkinson's disease), or for 2 weeks aMer stopping
the MAOI drug. If you do not know il your
prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product.

Ask a doctor before use if you have
■ heart disease    ■ high blood pressure
■ thyroid disease ■ diabetes
■ trouble urinating due to enlarged prostate gland
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic such as occurs with
smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use il you are
taking any other oral nasal decongestant or stimulant.

When using this product do not use more than
directed.

Stop use and ask a doctor if
■ you get nervous, diuy or sleepless
■ symptoms do not get better within 7 days or are
   accompanied by fever
■ cough lasts more than 7 days, comes back or is
   accompanied by fever, rash or persistent
   headache. These could be signs ot aserious
   condition.

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children. In case of overdose,
get medical help or contact aPoison Control Center
right away.

Directions
■ do not take more than 6 doses in any 24 hour period
■ this adult strength product is not intended for use in
children under 12 years of age

           AGE              DOSE

 Adults & children 12

     years & over

 2 teaspoons every 4 hours
 Children under 12 years 2 teaspoons every 4 hours

Other information
■ Keep carton for full Direction for use
■ store at 20-25ºC (68-77ºF)
■ do not refrigerate
■ dosage cup provided
■ sodium 3 mg per teaspoonful

Inactive ingredients
anhydrous citric acid, FD&C red no. 40, glycerin,
menthol, natural & artificial flavor, propylene glycol,
purified water, sodium benzoate, sorbitol solution,
sucralose

Questions? Call weekdays from 9:30 AM to 4:30
PM EST at 1-877·798-5944

Product Label

AP SAFE                         NDC 76821-504-24

COMPARE TO THE ACTIVE

INGREDIENT IN ROBITUSSIN®

PEAK COLD

MULTI-SYMPTOM COLD*

Adult Tussin

Multi-Symptom Cold

Dextromethorphan HBr / Guaifensesin /

Phenylephrine HCL

Cough Supressant / Expectorant /

Nasal Decongestant

Non-Drowsy

Relieves:
• Cough
• Mucus
• Nasal Congestion
• For Ages 12 and over

4 FL OZ (118 mL)

CF

DO NOT USE IF PRINTED SEAL UNDER
CAP IS TORN OR MISSING

5
1013430
3/20

*This product is not manufactured or distributed
by Plizer, owner of the registered trademark
Robitussin®

Manufactured by:
AptaPharma Inc.,
1533 Union Ave,
Pennsauken, NJ 08110

Ap·BX·05

Carton

504 TussinCF 4 OZ Box

Bottle

504 TussinCF 4 OZ Btl

res

TUSSIN CF 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-504
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-504-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/30/2020
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-504)

Revised: 12/2023
Document Id: 9560bce8-d705-4882-87cf-fde3c283513f
Set id: c005c6cf-7891-463e-b65d-1129ad4bf6ec
Version: 6
Effective Time: 20231230
 
AptaPharma Inc.