COLD TERMINATOR MAX- phenylephrine hcl, acetaminophen, guaifenesin tablet 
Provision Medical Products

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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Uses:

temporarily relieves these cold symptoms: • cough • sore throat

minor aches and pains • headaches • nasal congestion • helps loosen

phlegm (mucus) and thin bronchial secretions to make coughs more productive

temporarily reduces fever

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 a

Poison Control Center right away. Prompt

medical attention is critical for adults as well

as for children even if you do not notice any

signs or symptoms

Warnings:

Alcohol Warning: If you consume 3 or more alcoholic drinks

every day, ask your doctor whether you should take acetaminophen or other

pain relievers/fever reducers. Acetaminophen may cause liver damage.

Sore Throat Warning:

If sore throat is severe, persists for more than 2 days,

is accompanied or followed by a fever, headache, rash, nausea or vomiting,

consult a doctor promptly.

Drug Interaction Precaution:

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.

Do not use:

if using any other product containing any of the above active

ingredients or with other acetaminophen products, this will provide more than

the recommended dose (overdose) and could cause serious health concerns

Ask a doctor before use if you have:

• heart disease • high blood pressure

thyroid disease • diabetes • difficulty in urination due to enlargement of the

prostate gland

• persistant or chronic cough such as occurs with smoking,

asthma, chronic bronchitis, or emphysema or where cough is accompanied by

excessive phlegm (mucus)

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if:

• new symptoms occur • redness or swelling is

present

• pain gets worse or lasts for more than 7 days • fever gets worse or

lasts for more than 3 days

• nervousness, dizziness or sleeplessness occur

Directions:

Adults and children 12 years of age and older :take 2 tablets with water

every 6 to 8 hours, as needed; do not exceed 8 tablets in 24 hours or as

directed by a doctor.

Children under 12 years:ask a doctor

Inactive Ingredients:

croscarmellose sodium, dicalcium

phosphate, hypromellose, magnesium

stearate, microcrystalline cellulose, mineral

oil, polyethylene glycol, silicone dioxide,

stearic acid, talc and titanium dioxide.

ACTIVE INGREDIENT-ACETAMINOPHEN 325 MG, GUAIFENESIN 200 MG, PHENYLEPHRINE HCl 5 MG

PAIN RELIEVER/FEVER REDUCER, EXPECTORANT, NASAL DECONGESTANT

COLD TERMINATOR BOX

COLD TERMINATOR MAX 
phenylephrine hcl, acetaminophen, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2556
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
Product Characteristics
Colorpink (ROSE PINK) Scoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR14
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-2556-5250 in 1 CARTON04/03/201505/01/2023
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:69103-2556-6100 in 1 CARTON04/03/201505/01/2023
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/31/201505/01/2023
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(69103-2556)

Revised: 1/2023
 
Provision Medical Products