Label: DELSYM COUGH PLUS COLD NIGHT TIME- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution
- NDC Code(s): 63824-110-08
- Packager: RB Health (US) 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 January 11, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 packets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
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.
- with any other drug containing diphenhydramine, even one used on the skin
- 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
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- glaucoma
- breathing problems such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- a sodium-restricted diet
Ask a doctor or pharmacist before use if
- you are taking the blood thinning drug warfarin
- you are taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
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Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 packets in any 24-hour period
- adults and children 12 years of age and older: 1 packet every 4 hours
- Dissolve contents of one packet into 8 oz of hot water and stir; sip while hot. Consume within 15 minutes.
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 8 Packet Carton
NDC 63824-110-08
NEW!
MAX Strength*
Delsym®
COUGH +™ COLD
NIGHT TIME
Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)- ✓
- Cough
- ✓
- Nasal Congestion
- ✓
- Sore Throat
- ✓
- Body Aches
- ✓
- Fever
HONEY LEMON
Flavored MixFor Ages 12+
8 Packets
-
INGREDIENTS AND APPEARANCE
DELSYM COUGH PLUS COLD NIGHT TIME
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-110 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 650 mg Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 mg Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 10 mg Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) aspartame (UNII: Z0H242BBR1) D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Red No. 40 (UNII: WZB9127XOA) saccharin sodium (UNII: SB8ZUX40TY) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) sucrose (UNII: C151H8M554) Product Characteristics Color YELLOW Score Shape Size Flavor HONEY, LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-110-08 8 in 1 CARTON; Type 0: Not a Combination Product 04/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/01/2014 Labeler - RB Health (US) LLC (081049410)