COLD RELIEF SEVERE PAIN COUGH- acetaminophen,guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide tablet

Cold Relief Severe Pain Cough by

Drug Labeling and Warnings

Cold Relief Severe Pain Cough by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Acetaminophen 325 mg.Guaifenesin 200 mg Phenylephrine HCl 5 mg

PURPOSE

Pain Reliever, Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant

DOSAGE & ADMINISTRATION

Directions: adults and children 12 years of age and over take 2 tablets with water every 6-8 hours, as needed do not take more than 8 tablets in 24 hours children under 12 years of age do not give to children under 12 years of age

INDICATIONS & USAGE

Uses: or the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion cough helps loose phlegm (mucus) and thin bronchial secretions to make coughs more  productive temporarily reduces fever

WARNINGS

Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount, for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing any of the above active ingredients 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. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When
using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness,or sleeplessness occur pain or nasal congestion or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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.

INACTIVE INGREDIENT

Inactive ingredients:
Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

COLD RELIEF SEVERE PAIN COUGH  
acetaminophen,guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-456
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (FR12)	Size	12mm
Flavor		Imprint Code	FR12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-456-02	2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/15/2012

Labeler - Select Corporation (053805599)