Caring Mill Nighttime: Package Insert and Label Information

CARING MILL NIGHTTIME- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled
FSA Store Inc.

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.

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat and bronchial irritation
minor aches and pains
runny nose and sneezing
sore throat
headache
fever

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, lasts 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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
persistent or chronic cough as occurs with smoking, asthma, or emphysema
trouble urinating due to an 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

excitability may occur, especially in children
be careful when driving a motor vehicle or operating machinery
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
marked drowsiness may occur

Stop use and ask a doctor if

pain or cough gets worse or lasts more than 7 days
redness or swelling is present
fever gets worse or lasts more than 3 days
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.

Overdose warning: 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 – see overdose warning
do not exceed 4 doses per 24 hours

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Inactive ingredients

D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Vicks® NyQuil® Cold & Flu active ingredients

Nighttime

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Acetaminophen

Dextromethorphan HBr

Doxylamine succinate

Cold & Flu

Night Time Relief

16 Softgels

Actual Size

nighttime image 1
(click image for full-size original)

nighttime image 2
(click image for full-size original)

CARING MILL NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81522-056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SORBITOL
SORBITAN
Product Characteristics
Color GREEN (clear) Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 056
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81522-056-73 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (81522-056-73)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/03/2021
Labeler — FSA Store Inc. (049283340)

Revised: 09/2021 FSA Store Inc.

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