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NDC 69842-0506-04 Multi Symptom NightTime Cold 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL Details
Multi Symptom NightTime Cold 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL
Multi Symptom NightTime Cold is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 69842-0506 |
|---|---|
| Product ID | 69842-506_9f35dd1a-cc20-4aed-824f-8604692d4643 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Multi Symptom NightTime Cold |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen Diphenhydramine HCI Phenylephrine HCI |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 325; 12.5; 5 |
| Active Ingredient Units | mg/10mL; mg/10mL; mg/10mL |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | CVS Pharmacy |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 69842-0506-04 (69842050604)
| NDC Package Code | 69842-506-04 |
|---|---|
| Billing NDC | 69842050604 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (69842-506-04) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2018-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 991019f8-b4c2-45b8-ad71-fe099e6d99a7 Details
Active ingredients (in each 10 mL)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
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
- in a child who is taking 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product
- with any other drug containing diphenhydramine, even one used on skin.
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product
- to make a child sleepy
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- a breathing problem such as chronic bronchitis
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfain
- taking sedative or tranquilizers
When using these products
- do not use more than directed
- marked drowsiness may occur
- excitablity may occur, especially in children
- sedatives and tranquilizer may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or last more than 5 days
- redness or swelling is present
- new symptoms occurs
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious conditions.
.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see Overdose warning)
- do not give more than 5 doses in any 24-hour period
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 days unless directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- dose as follows or as directed by a doctor
- children 6 to under 12 years of age: 10 mL every 4 hours
-
children under 6 years of age: do not use
Other information
Inactive ingredients
Principal Display Panel
Compare to the active ingredients in Children's Mucinex® Night Time Multi-Symptom Cold**
Children's
multi-symptom
Nighttime Cold
ACETAMINOPHEN 325 mg (pain reliever / fever reducer)
DIPHENHYDRAMINE HCI 12.5 mg (Antihistamine-Cough Suppressant)
PHENYLEPHRINE HCI 5 mg (Nasal Decongestant)
Relieves:
Nasal congestion
Reduces fever
Soothes cough and sore throat
Ages 6 to 11 Years
Berry Flavor Liquid
Dosage Cup Included
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
**This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Night Multi-Symptom Time Cold
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
CVS.com® 1-800-SHOP CVS
INGREDIENTS AND APPEARANCE
| MULTI SYMPTOM NIGHTTIME COLD
acetaminophen diphenhydramine hci phenylephrine hci liquid |
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| Labeler - CVS Pharmacy (062312574) |