COLTALIN-ND (coltalin-nd (acetaminophen, phenylephrine hydrochloride) tablet) Dailymed
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Otc - Active Ingredient Section
Active ingredients (in each tablet)Acetaminophen 325 mgPhenylephrine hydrochloride 5 mg
Otc - Purpose Section
Purpose Pain reliever-fever reducerNasal decongestant
Indications & Usage Section
Uses ■temporarily relieves these symptoms due to a cold, the flu, or hay fever:   ■minor aches and pains   ■sore throat   ■headache   ■sinus congestion and pressure   ■nasal congestion■temporarily reduces fever
Warnings Section
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if:â– adult takes more than 12 tablets in 24 hours, which 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.for fever for more than 3 days, unless directed by a physicianâ– 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 whether a 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– difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if the user is â– taking the blood thinning drug warfarinâ– taking a prescription drug and you do not know if it contains an MAOI
Otc - When Using Section
When using this product â– do not exceed recommended dosage
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 is severe■sore throat persists for more than 2 days■sore throat is accompanied or followed by:   ■fever   ■headache   ■rash   ■nausea   ■vomiting■nervousness, dizziness, or sleeplessness occur■fever gets worse or lasts more than 3 days■any of the following occurs (these could be signs of a serious condition):   ■new symptoms occur   ■pain or fever persist or gets worse   ■redness or swelling is present
Warnings Section
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 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, FDC red no. 40 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-ND
Non-Drowsy
Safely Sealed
NDC 51467-013-01
Acetaminophen - Pain Reliever-Fever ReducerPhenylephrine Hydrochloride - Nasal Decongestant
Cold, Flu & Hay Fever Multi-Symptom Reliefâ– Minor Aches & Pain, Sore Throatâ– Headache, Feverâ– Nasal Congestion, Sinus Pressure/Drainage
24 Tablets
In Individually Sealed Strip
Aspirin Free
Package Label.principal Display Panel
COLTALIN-ND
Non-Drowsy
Safely Sealed
NDC 51467-013-02
Acetaminophen - Pain Reliever-Fever ReducerPhenylephrine Hydrochloride - Nasal Decongestant
Cold, Flu & Hay Fever Multi-Symptom Reliefâ– Minor Aches & Pain, Sore Throatâ– Headache, Feverâ– Nasal Congestion, Sinus Pressure/Drainage
36 Tablets
In Individually Sealed Strip
Aspirin Free
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