COLD TABS II- acetaminophen, guaifenesin and phenylephrine hcl tablet

COLD TABS II by

Drug Labeling and Warnings

COLD TABS II by is a Otc medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., ULTRA SEAL CORPORATION, ULTRA TAB LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT IN EACH TABLET-

Acetaminophen 325 mg

Guaifenesein 200 mg

Phenylephrine HCl 5 mg

PURPOSE

pain reliever/fever reducer

expectorant

decongestant

INDICATIONS & USAGE

Uses: temporarily: relieves nasal congestion associated with sinusitis relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies relieves sinus congestion and pressure, helps decongest sinus openings and passages restores free breathing helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive. temporarily relieves minor aches, pains, and fever associated with: headache common cold toothache backache muscular aches menstrual cramps

WARNINGS

Warnings:

Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: you take more than 8 tablets in 24 hours you take with other drugs containing acetaminophen (prescription or non-prescription) you have 3 or more alcoholic drinks every day while using this product

Do not use: with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. more than the recommended dose for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor when using this product do not exceed recommended dose 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before

taking this product.

Stop use and ask a doctor if: symptoms do not improve pain or fever persists or gets worse new symptoms occur redness or swelling is present nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.

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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding baby, 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.

DOSAGE & ADMINISTRATION

Directions:

Adults and children 12 years of age and older:  Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or asdirected by a doctor.

Children under 12 years: Consult a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: FD&C Red #40, microcrystalline cellulose, povidone, sodium starch glycolate, starch, and stearic acid.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD TABS II 
acetaminophen, guaifenesin and phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-106
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink (ROSE PINK)	Score	no score
Shape	ROUND	Size	12mm
Flavor	CHERRY	Imprint Code	FR8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-106-68	100 in 1 CARTON	04/10/2015
1	NDC: 67060-106-02	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	04/10/2015

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA SEAL CORPORATION		085752004	pack(67060-106)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-106)