Nighttime Cold and Flu (acetaminophen 325 mg dextromethorphan hydrobromide 15 mg doxylamine succinate 6.25 mg) Dailymed
Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Headache Sleep Initiation and Maintenance Disorders Rhinitis, Allergic, Perennial
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Active Ingredients (in Each Capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Purpose
Pain reliever/ fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches/pains
- fever
- runny nose & sneezing
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning:If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Otc - Do Not Use Section
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 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.
- To make a child sleep
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- cough with excessive phlegm(mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- difficulty in urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- do not exceed the recommended dosage
- do not use for more than 7 days
- excitability may occur especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Otc - Stop Use Section
Stop use and Ask a doctor if
- you get nervous, dizzy, or sleepless
- swelling or redness is present
- symptoms do not get better or are accompanied by a fever that lasts more than 3 days or if new symptoms occur
- cough lasts more than 7 days (adults) or 5 days (children), recurs or is accompanied by fever, rash, or persistent headache.
These may be signs of a serious condition.
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.
Overdose warning: Taking more than the recommended dose (overdose) could cause serious health problems.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 .
Directions
- take only as directed - see overdose warning
- do not exceed 4 doses per 24 hours
Adults and children 12 years of age and over
Swallow 2 softgels with water every 6 hours
Children 4 to 12 years of age
ask a doctor
children under4 years o9f age
do not use
If taking NIGHTTIME and DAYTIME softgels carefully read each label to insure correct dosing.
Other Information
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain phenylpropanolamine (PPA)
Inactive Ingredients
D&C Yellow # 10, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink
Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China
Principal Display Panel - Shipping Label
NIGHTTIME COLD AND FLU CAPSULES
Quantity : 4000 Capsules NDC. No : 53345-006-01
IMPORTANT:
Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate.
CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"
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DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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