NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
AiPing Pharmaceutical, Inc.
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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Nighttime Cold and Flu Relief
ACTIVE INGREDIENTS (IN EACH SOFTGEL)
Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg
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 for 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 product 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 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, & tranquilizers may increase drowsiness
DIRECTIONS
- take only as directed - see Overdose warning
- do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over |
2 softgels with water every 6 hrs |
|
children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
OTHER INFORMATION
- store at room temperature
TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.
INACTIVE INGREDIENTS
D&C Yellow # 10, FD&C Blue # 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.
PRINCIPAL DISPLAY PANEL
Nighttime Softgels
NDC: 11788-017-00
Quantity: 4,500 Softgels
WARNING:
KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.
| NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled |
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| Labeler - AiPing Pharmaceutical, Inc. (079674526) |
| Registrant - AiPing Pharmaceutical, Inc. (079674526) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Anshi Pharmaceutical (Zhongshan) Inc. | 528101821 | manufacture(11788-017) , analysis(11788-017) , label(11788-017) , pack(11788-017) | |