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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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