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- NDC Code(s): 58602-769-78, 58602-769-79
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 28, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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- Active ingredients (in eachcapsule)
Acetaminophen USP 325 mg
Dextromethorphan HBr USP 15 mg
Doxylamine succinate USP 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 8 capsules in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every daywhile using this product
Allergy Alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
• skin reddening
• blisters
• rash
If a skin reaction occurs, stop use and seek medical help right away
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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.
- 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, 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.
- If pregnant or breast-feeding,
ask a health professional before use.
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Directions
- take only as directed
- do not exceed 8 capsulesper 24 hrs
adults & children 12 yrs & over 2 capsules with water every6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use - Other information
- store at room temperature
- Inactive ingredients
D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide
Questions or comments?call 1-855-274-4122
- QUESTIONS
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown RoadEast Windsor, NJ 08520
Made in India
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - (24 Capsules Bottle)
AUROHEALTH
NDC 58602-769-78
Compare to the active ingredients
in VICKS® NyQuil® Cold & Flu
Nighttime Relief LiquiCaps®*
Nighttime Relief
Cold & Flu
Acetaminophen, Dextromethorphan HBr and
Doxylamine Succinate Capsules
325 mg/15 mg/6.25 mg- Headache, Fever,Sore Throat,
Minor Aches & Pains
- Sneezing, Runny Nose
- Cough
Actual Size
24
Capsules
- INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-769 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code Q07 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-769-78 3 in 1 CARTON 06/29/2024 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:58602-769-79 1 in 1 CARTON 06/29/2024 2 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/29/2024 Labeler -Aurohealth LLC(078728447)
Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 ANALYSIS(58602-769) , MANUFACTURE(58602-769)
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More Info on this Drug
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View Labeling Archives for this drug
NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule
Number of versions: 4
| Published Date (What is this?) | Version | Files |
|---|---|---|
| May 12, 2025 | 4 (current) | download |
| Nov 23, 2023 | 3 | download |
| Dec 8, 2020 | 2 | download |
| Dec 31, 2019 | 1 | download |
RxNorm
NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule
Under Review - Editing is pending for RxNorm. If in scope, these drugs will include RxNorm normal forms when editing is complete.
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NDC Codes
NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 58602-769-78 |
| 2 | 58602-769-79 |
