NITETIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
PuraCap Pharmaceutical LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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NiteTime
Active Ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
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 for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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 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 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 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, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- pain 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.
Keep out of reach of children.
Overdose warning: Taking more than directed can cause serious health problems. 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 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 4 hours |
| children 4 to under 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
- When using other Nighttime or Daytime products, carefully read each label to insure correct dosing
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
Product Labeling
MULTI-SYMPTOM
NiteTime Liquid Capsules
NDC 51013-106-01
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
pain reliever, fever reducer, cough suppressant,antihistamine
fever, headache, sore throat, coughing, minor aches and pains, runny nose and sneezing
Compare to the active ingredients in Vicks® NyQuil®*
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
| NITETIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled |
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| Labeler - PuraCap Pharmaceutical LLC (962106329) |
| Registrant - Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd (421293287) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd | 421293287 | manufacture(51013-106) , analysis(51013-106) | |