Cough and Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Cough and Cold

Progela, S.A. de C.V.

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients (in each capsule)




Purpose

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Antitussive

Uses

Uses Temporarily relieve: •muscular aches •headache • fever •runny nose •sneezing •itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies •nasal congestion •temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants

Warnings
Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

•more than 12 capsules in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this product

Do not exceed recommended dosage

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. •if you are allergic to acetaminophen or any of the inactive ingredients in this product •in excess of recommended dosage • 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 •a breathing problem such as emphysema or chronic bronchitis •glaucoma •heart disease• high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •a cough that lasts or is chronic such as occurs with asthma •a 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 •excitability may occur, especially in children •may cause drowsiness •alcohol, sedatives and tranquilizers may increase drowsiness effect •use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if •pain gets worse or lasts more than 10 days •fever gets worse or lasts more than 3 days •new symptoms occur •redness or swelling is present •nervousness, dizziness, or sleeplessness occur •symptoms persists for more than 7 days, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of the reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions Adults and children under 12 years of age •do not take more than directed (see overdose warning) •take 2 capsule every 4 hours. •do not take more than 12 capsules in 24 hours •do not use for more than 10 days unless directed by a doctor under 12 years of age •ask a doctor

Inactive Ingredients DC Red No. 33, FDC Blue No. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, polyethylene glycol, water

Cough and Cold

Cough and Cold

Acetaminophen Chlorpheniramine Maleate Dextromethorphan Hydrobromide Phenylepherine Hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:28623-250
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 250 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 33
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 600
POLYETHYLENE GLYCOL 1000
povidone
propylene glycol
water

Product Characteristics

Color Size Imprint Code Shape
blue (Sky Blue) 10 mm Xtra CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:28623-250-01 20 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-03-01


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Be sure to consult your doctor before taking any medication!
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