Label: NIGHT TIME SINUS AND CONGESTION- acetaminophen, doxylamine succinate, phenylephrine hcl capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-733-16 - Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 12, 2015
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
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Uses
- temporarily relieves symptoms due to common cold
- minor aches and pains
- headache
- fever
- runny nose and sneezing
- nasal congestion
- sinus congestion & pressure
- temporarily relieves symptoms due to hay fever or other upper respiratory allergies
- minor aches and pains
- headache
- runny nose and sneezing
- itching of the nose or throat, and itchy, watery eyes
- nasal congestion
- sinus congestion & pressure
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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 every day while using this product
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
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use ifyou 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
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
NIGHT TIME SINUS AND CONGESTION
acetaminophen, doxylamine succinate, phenylephrine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-733 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE K12 (UNII: 333AG72FWJ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 47A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-733-16 8 in 1 BLISTER PACK 1 2 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/12/2015 Labeler - Chain Drug Consortium, LLC (101668460) Establishment Name Address ID/FEI Business Operations Accucaps Industries Limited 248441727 analysis(68016-733) , manufacture(68016-733) Establishment Name Address ID/FEI Business Operations Accucaps Industries Limited Strathroy 243944050 analysis(68016-733) , manufacture(68016-733) Establishment Name Address ID/FEI Business Operations Legacy Pharmaceutical Packaging 969852743 pack(68016-733)
