COLD TERMINATOR MAX- phenylephrine hcl, acetaminophen, guaifenesin tablet

Cold Terminator Max by

Drug Labeling and Warnings

Cold Terminator Max by is a Otc medication manufactured, distributed, or labeled by Provision Medical Products, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health

professional before use.

KEEP OUT OF REACH OF CHILDREN

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

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

PURPOSE

PAIN RELIEVER/FEVER REDUCER, EXPECTORANT, NASAL DECONGESTANT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink (ROSE PINK)	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR14
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-2556-5	250 in 1 CARTON	04/03/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69103-2556-6	100 in 1 CARTON	04/03/2015
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/31/2015

Labeler - Provision Medical Products (036936831)

Registrant - Provision Medical Products (036936831)

Establishment
Name	Address	ID/FEI	Business Operations
Ultraseal Corporation		085752004	pack(69103-2556)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(69103-2556)