COLTALIN-DM (acetaminophen 325 mg chlorpheniramine maleate 2 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed
Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride is used for the treatment of Cough Urinary Bladder Neck Obstruction Duodenal Obstruction Infant, Newborn Infant, Premature Peptic Ulcer Prostatic Hyperplasia Rhinitis, Allergic, Perennial Status Asthmaticus Urticaria Glaucoma, Angle-Closure Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular
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Otc - Active Ingredient Section
Active ingredients (in each tablet) Acetaminophen 325 mgChlorpheniramine maleate 2 mgDextromethorphan hydrobromide 10 mgPhenylephrine hydrochloride 5 mg
Otc - Purpose Section
Purpose ​s Pain reliever-fever reducerAntihistamineCough suppressantNasal decongestant
Indications & Usage Section
Uses ■temporarily relieves these symptoms due to a cold, the flu, or hay fever:  ■minor aches and pains  ■headache  ■sore throat  ■nasal congestion  ■runny nose  ■sinus congestion and pressure  ■cough due to minor throat and bronchial irritation  ■sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever■temporarily reduces fever■promotes nasal and/or sinus drainage
Warnings Section
Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur ifâ– adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this productâ– child takes more than 5 doses in 24 hoursâ– taken with other drugs containing acetaminophenâ– adult has 3 or more alcoholic drinks everyday while using this product
Otc - Do Not Use Section
Do not use â– with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.â– if the user is 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.
Otc - Ask Doctor Section
Ask a doctor before use if the user has â– heart diseaseâ– high blood pressureâ– diabetesâ– glaucomaâ– liver diseaseâ– thyroid diseaseâ– a high feverâ– a breathing problem such as emphysema or chronic bronchitisâ– difficulty in urination due to enlargement of the prostate glandâ– a persistent cough
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if the user is â– taking sedatives or tranquilizersâ– taking the blood thinning drug warfarin
Otc - When Using Section
When using this product â– do not exceed recommended dosage â– may cause excitability especially in childrenâ– do not drive or operate machineryâ– avoid alcoholic beveragesâ– may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
Otc - Stop Use Section
Stop use and ask a doctor if ■pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)■sore throat persists for more than 2 days■nasal congestion is accompanied by fever■nervousness, dizziness, or sleeplessness occur■any of the following occurs (these could be signs of a serious condition):  ■fever gets worse or lasts more than 3 days  ■a severe sore throat  ■sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting  ■redness or swelling is present  ■new symptoms occur  ■cough persists for more than 1 week, tends to recur, or is accompanied by fever rash, or persistent headache
Do not give to children under 6 years of age unless directed by a doctor.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children Section
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 Section
Directions â– adults and children 12 years of age and over: 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctorâ– children 6 to under 12 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctorâ– children under 6 of age : consult a doctor
Storage And Handling Section
Other information â– keep tightly sealedâ– store between below 25 C (77 F) in a dry place, away from direct sunlight
Inactive Ingredient Section
Inactive ingredients colloidal silicon dioxide, corn starch, D&C yellow no. 10 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate
Otc - Questions Section
Questions or comments? (888) 221-3496 M-F 9 am to 5 pm â– you may also report serious side effects to this phone number
Package Label.principal Display Panel
COLTALIN-DM
Safely Sealed
NDC 51467-007-01
Acetaminophen - Pain Reliever-Fever ReducerChlorpheniramine Maleate - AntihistamineDextromethorphan Hydrobromide - Cough SuppressantPhenylephrine Hydrochloride - Nasal Decongestant
Cough, Cold & Flu Multi-Symptom Reliefâ– Minor Aches & Pain, Sore Throatâ– Headache, Feverâ– Nasal Congestion, Sinus Pressure/Drainageâ– Coughâ– Sneezing, Runny Noseâ– Itchy, Watery Eyes
24 Tablets
In Individually Sealed Strip
Aspirin Free
Package Label.principal Display Panel
COLTALIN-DM
Safely Sealed
NDC 51467-007-02
Acetaminophen - Pain Reliever-Fever ReducerChlorpheniramine Maleate - AntihistamineDextromethorphan Hydrobromide - Cough SuppressantPhenylephrine Hydrochloride - Nasal Decongestant
Cough, Cold & Flu Multi-Symptom Reliefâ– Minor Aches & Pain, Sore Throatâ– Headache, Feverâ– Nasal Congestion, Sinus Pressure/Drainageâ– Coughâ– Sneezing, Runny Noseâ– Itchy, Watery Eyes
36 Tablets
In Individually Sealed Strip
Aspirin Free
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