Complete SPL Sections
Active ingredients (in each Softgel)
OTC - ACTIVE INGREDIENT SECTION
Acetaminophen USP 325 mg Dextromethorphan Hydrobromide USP 10 mg Doxylamine succinate USP 6.25 mg Phenylephrine Hydrochloride USP 5 mg
Purpose
OTC - PURPOSE SECTION
Pain reliever/Fever reducer Cough suppressant Antihistamine Nasal decongestant
Uses
INDICATIONS & USAGE SECTION
temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation Cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores free breathing through the nose promotes nasal and/or sinus drainage
Warnings
WARNINGS SECTION
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 Softgels in 24 hrs, 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 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 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
OTC - DO NOT USE SECTION
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 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
OTC - ASK DOCTOR SECTION
liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
OTC - ASK DOCTOR/PHARMACIST SECTION
taking sedatives or tranquilizers taking the blood thinning drug warfarin
When using this product
OTC - WHEN USING SECTION
do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, & tranquilizers may increase drowsiness
Stop use and ask a doctor if
OTC - STOP USE SECTION
you get nervous, dizzy or sleepless pain, 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.
If pregnant or breast-feeding,
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a health professional before use.
Keep out of reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdosage
OVERDOSAGE SECTION
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
DOSAGE & ADMINISTRATION SECTION
take only as directed do not exceed 8 Softgels per 24 hrs Adults & children 12 years & over 2 softgels with water every 4 hours Children 4 to under 12 years Ask a doctor Children under 4 years Do not use
Other information
OTHER SAFETY INFORMATION
Store at no greater than 25ºC
Inactive ingredients
INACTIVE INGREDIENT SECTION
FD&C Blue No.1, D&C Yellow No.10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water and sorbitol sorbitan solution.
TAMPER EVIDENT
SPL UNCLASSIFIED SECTION
This package is safety-sealed. Use only if blisters are intact. If difficult to open, use scissors.
Manufactured by
SPL UNCLASSIFIED SECTION
Softgel Healthcare Pvt. Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam Village, Kancheepuram District, Tamilnadu - 603 103, India. Mfg. Lic. No.: XXXXXXXXXXXX