![MULTI SYMPTOM NIGHTTIME COLD (ACETAMINOPHEN DIPHENHYDRAMINE HCI PHENYLEPHRINE HCI) LIQUID [CVS PHARMACY]](https://medic.hrt.org//dailymed/images/991019f8-b4c2-45b8-ad71-fe099e6d99a7/childrens-mucus-nighttime-multi-symptom-cold-berry-1.jpg)
| NDC | 69842-506-04 |
| Set ID | 991019f8-b4c2-45b8-ad71-fe099e6d99a7 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | CVS Pharmacy |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 10 mL)
- Purpose
- Uses
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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.
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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
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children under 6 years of age: do not use
- Other information
- Inactive ingredients
- Questions or comments?
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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
- Product Label
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INGREDIENTS AND APPEARANCE
MULTI SYMPTOM NIGHTTIME COLD
acetaminophen diphenhydramine hci phenylephrine hci liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-506 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYL GALLATE (UNII: 8D4SNN7V92) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY (Mixed) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-506-04 1 in 1 BOX 04/30/2018 1 118 mL in 1 BOTTLE, PLASTIC; 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 04/30/2018 Labeler - CVS Pharmacy (062312574)
