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NDC 70000-0516-01 NightTime Cold and Flu 325; 15; 6.25 mg/1; mg/1; mg/1 Details
NightTime Cold and Flu 325; 15; 6.25 mg/1; mg/1; mg/1
NightTime Cold and Flu is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 70000-0516-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 70000-0516-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 70000-0516-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Doxylamine
Product Information
| NDC | 70000-0516 |
|---|---|
| Product ID | 70000-0516_bf2ddad9-dcf5-4364-82be-ddb321d14685 |
| Associated GPIs | 43998903350120 |
| GCN Sequence Number | 059455 |
| GCN Sequence Number Description | DM/acetaminophen/doxylamine CAPSULE 15MG-325MG ORAL |
| HIC3 | B4G |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN ANTIHIST-ANALGESIC COMB |
| GCN | 25094 |
| HICL Sequence Number | 025663 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/ACETAMINOPHEN/DOXYLAMINE |
| Brand/Generic | Generic |
| Proprietary Name | NightTime Cold and Flu |
| Proprietary Name Suffix | Multi Symptom |
| Non-Proprietary Name | ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 325; 15; 6.25 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
| Labeler Name | Cardinal Health (Leader) 70000 |
| Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0516-01 (70000051601)
| NDC Package Code | 70000-0516-1 |
|---|---|
| Billing NDC | 70000051601 |
| Package | 16 BLISTER PACK in 1 CARTON (70000-0516-1) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2019-08-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.13222 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | NIGHTTIME COLD-FLU RLF SFTGL |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL a8460fc9-2d08-4e5f-8dd3-5135ecda5923 Details
Active Ingredients (in each softgel)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while 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 of pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor of pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
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 the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in 24 hours
- adults and children 12 years and over: take 2 softgels with water every 6 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Inactive Ingredients
Principal Display Panel
COMPARE TO VICKS® NYQUIL® COLD & FLU LIQUICAPS® active ingredients†
Nighttime | Multi-Symptom
Cold & Flu Relief
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever / Fever Reducer | Cough Suppressant | Antihistamine
Relieves: Fever, Sore Throat, Cough, Runny Nose, Sneezing, Headache, Aches and Pains
SOFTGELS**
**Liquid-Filled Capsules
†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, NyQuil®, and LiquiCaps® are registered trademarks of The Procter & Gamble Company.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
INGREDIENTS AND APPEARANCE
| NIGHTTIME COLD AND FLU
MULTI SYMPTOM
acetaminophen dextromethorphan hydrobromide doxylamine succinate capsule, liquid filled |
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| Labeler - Cardinal Health (Leader) 70000 (063997360) |