Cough and Cold by Progela, S.A. de C.V. Drug Facts
Cough and Cold by
Drug Labeling and Warnings
Cough and Cold by is a Otc medication manufactured, distributed, or labeled by Progela, S.A. de C.V.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
COUGH AND COLD XL3 XTRA- acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride capsule, liquid filled
Progela, S.A. de C.V.
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.
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Drug Facts
Active ingredients (in each capsule)
Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 10 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves: muscular aches and pains headache temporarily reduces fever runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever or other upper respiratory allergies pressure nasal congestion 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 tablets in 24 hours, which is the máximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening blisters rash
if a skin reaction occurs, stop use and seek medical help right away.
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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in this product
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 for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor if you are taking sedatives or tranquilizers, without first consulting your doctor.
Ask a doctor before use if you have
liver disease a breathing problem such as emphysema glaucoma heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland
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 avoid alcohlic beverages
Stop use and ask a doctor if
symptoms do not improve pain, nasal congestion or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur cough comes back or occurs with a rash or a headache tha lasts. These could be the signs of a serious condition nervousness, dizziness, or sleeplessness occur fever gets worse or lasts for more than 3 days.
Keep out of reach of children
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 (1-800-222-1222) 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
Do not use more than directed (see overdose warning) do not take this product form more than 10 days unless directed by a doctor Adults and children 12 years of age and over take 2 capsule every 4 hours. Do not take more than 12 capsules in 24 hours Children under 12 years of age Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdoes) may cause liver damage. Do not exceed recommedned dosage
Other information
Store at room temperature to 15º-30ºC (59º-86ºF) do not use if package is torn or damaged
Inactive ingredients
D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, propylene glycol, purified water
| COUGH AND COLD
XL3 XTRA
acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride capsule, liquid filled |
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| Labeler - Progela, S.A. de C.V. (812374932) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Progela, S.A. de C.V. | 812374932 | manufacture(28623-250) | |