Cold Terminator Max: Package Insert and Label Information

COLD TERMINATOR MAX- phenylephrine hydrochloride, acetaminophen and 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.

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
(click image for full-size original)

COLD TERMINATOR MAX
phenylephrine hcl, acetaminophen, guaifenesin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2556
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A CORN
SILICON DIOXIDE
FD&C RED NO. 40
STEARIC ACID
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
Product Characteristics
Color pink (ROSE PINK) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code FR14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69103-2556-5 250 PACKET in 1 CARTON contains a PACKET
1 2 TABLET in 1 PACKET This package is contained within the CARTON (69103-2556-5)
2 NDC:69103-2556-6 100 PACKET in 1 CARTON contains a PACKET
2 2 TABLET in 1 PACKET This package is contained within the CARTON (69103-2556-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/31/2015 05/01/2023
Labeler — Provision Medical Products (036936831)
Registrant — Provision Medical Products (036936831)
Establishment
Name Address ID/FEI Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture (69103-2556)

Revised: 01/2023 Provision Medical Products

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